Who else makes this device?

Name: Advanced Instruments Osmo1® Single-Sample Micro-Osmometer
Brand: Advanced Instruments Osmo1® Single-Sample Micro-Osmometer

Clinical Chemistry › Laboratory InstrumentsOsmometer For Clinical Use

Advanced Instruments Osmo1® Single-Sample Micro-Osmometer

With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain…

Registry build 21.09.26

With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument.

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 Instruments Osmo1® Single-Sample Micro-Osmometer
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	2020-09-21
Record revised	2026-06-19 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	serial number

Catalogue Numbers

Catalogue numbers for Advanced Instruments Osmo1® Single-Sample Micro-Osmometer
Catalogue number	Size	Status
Osmo1		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

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
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.