Panels › Hematology › Product code KSG · Class 2

Media, Potentiating For In Vitro Diagnostic Use

Regulation 864.9600

0510(k)s in 12 months (13 all time)

0recalls in 12 months (1 all time)

0recalls that name a 510(k)

Top companies in KSG

Company	510(k)s	Recalls
Biological Corp. of America	3	0
Ortho Diagnostics, Inc.	2	0
Bd Becton Dickinson Vacutainer Systems Preanalytic	1	0
Dade, Baxter Travenol Diagnostics, Inc.	1	0
Fisher Scientific Co., LLC	1	0
Gamma Biologicals, Inc.	1	0
Gotham Biologics, Inc.	1	0
Hyland Therapeutic Div., Travenol Laboratories	1	0
Miles Laboratories, Inc.	1	0
Ortho Clinical Diagnostics Inc	0	1

Date	Firm and product	Code	Linked 510(k)
Oct 14, 2019	Ortho Clinical Diagnostics Inc Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the Terminated	KSG	None listed

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