Who else makes this device?

Name: Advanced Instrument OsmoPRO MAX
Brand: Advanced Instrument OsmoPRO MAX

Clinical Chemistry › Laboratory InstrumentsOsmometer For Clinical Use

Advanced Instrument OsmoPRO MAX

The OsmoPRO MAX provides osmolality measurement of serum, plasma, and urine, and is intended for use by trained healthcare professionals. Osmolality is a valuable clinical tool used in the…

Registry build 21.09.26

The OsmoPRO MAX provides osmolality measurement of serum, plasma, and urine, and is intended for use by trained healthcare professionals. Osmolality is a valuable clinical tool used in the diagnosis and treatment of patients. It is a quick and effective test to help evaluate the body’s water balance or its ability to produce and concentrate urine, to investigate low sodium levels (hyponatremia), to detect the presence of toxins in the body, and to monitor the osmolality of patients undergoing osmotically active drug therapies such as mannitol, which is used to treat cerebral edema.

4manufacturers in China registered for this device type

1catalogue number

7510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Shandong (2), Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JJM
Manufacturer	City	Province	Registered as	Device types
Guangzhou Four E’s Scientific Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	61
Infitek Co., Ltd.	Shanghai	Shanghai	Manufacturer	49
Labpeak Co., Ltd.	Jinan	Shandong	Manufacturer	43
Scitek Global Co., Ltd.	Jinan	Shandong	Manufacturer	43

Record

Regulatory record for Advanced Instrument OsmoPRO MAX
Listed by	Advanced Instruments, LLC, United States
FDA product code	JJM
Device type	Osmometer For Clinical Use
Device class	Class 1
Regulation	21 CFR 862.2730
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2026-06-18

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Advanced Instrument OsmoPRO MAX
Catalogue number	Size	Status
OsmoPRO MAX		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
FreezePoint® Freezing Point Osmometer	ELITechGroup Inc	4
Multi-OSMETTE	Precision Systems, Inc.	3
Micro-OSMETTE	Precision Systems, Inc.	2
Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer	Advanced Instruments, LLC	2
Osmette Sample Tubes, 30 ul	Precision Systems, Inc.	2
Osmette III	Precision Systems, Inc.	2
Osmette XL	Precision Systems, Inc.	2
Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500	Advanced Instruments, LLC	2
Osmette A	Precision Systems, Inc.	2
Touch Micro-OSMETTE	Precision Systems, Inc.	1
Multi-OSMETTE Carousel, Spare	Precision Systems, Inc.	1
Micro-OSMETTE Sample Tubes, 50 ul	Precision Systems, Inc.	1

Showing 12 of 60. All products under Osmometer For Clinical Use

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K965036	1997-02-20
K962056	1996-07-11
K925970	1993-07-09
K911092	1991-05-22
K873642	1987-10-20
K832783	1983-11-28
K790611	1979-06-15

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Advanced Instrument OsmoPRO MAX
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Advanced Instruments, LLC	UDI-DI	2024-03-11	Class II	Under Investigation by firm	System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.	58 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.