Who else makes this device?

Name: ISE Buffer
Brand: ISE Buffer

Clinical Chemistry › Test SystemsCalibrator, Secondary

ISE Buffer

For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine.

Registry build 21.09.26

1manufacturer

1catalogue number

9510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JIT
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	4

Record

Regulatory record for ISE Buffer
Listed by	Diamond Diagnostics Inc., Hungary
FDA product code	JIT
Device type	Calibrator, Secondary
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Contract manufacturer, Manufacturer, Exporter
Record published	2023-06-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for ISE Buffer
Catalogue number	Size	Status
OY-AUH1011D		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Vitros	Ortho-Clinical Diagnostics, Inc.	39
Exact Diagnostics	Exact Diagnostics	30
Architect	Abbott Medical	26
Architect	Abbott Ireland	24
Alinity	Abbott Medical	18
Alinity	Abbott Ireland	16
Architect	Abbott Laboratories	15
Architect	Abbott Ireland Diagnostics	11
Alinity	Abbott Ireland Diagnostics	11
JAS Diagnostics	Drew Scientific, Ltd.	10
BioPlex 2200	Bio-Rad Laboratories Inc.	8
AU	Beckman Coulter, Inc.	6

Showing 12 of 391. All products under Calibrator, Secondary

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K133751	2014-08-08
K121027	2012-12-20
K120591	2012-04-17
K093357	2010-06-24
K071039	2007-08-08
K033060	2004-03-04
K031159	2003-06-25
K020596	2002-03-23
K013850	2001-12-21

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.