Behring Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 145 products

Total Devices145

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K973832	OPUS HLH CONTROLS	JJX	1997-10-27	View
510(k)	K972929	N ANTISERUM TO HUMAN ALBUMIN	DCF	1997-10-20	View
510(k)	K972840	N ANTISERUM TO HUMAN TRANSFERRIN	DDG	1997-10-17	View
510(k)	K973202	MODIFICATION OF OPUS FERRITIN TEST SYSTEM	DBF	1997-09-12	View
510(k)	K972316	OPUS D-DIMER	GHH	1997-09-09	View
510(k)	K972116	VON WILLEBRAND REAGENT	GGP	1997-07-25	View
510(k)	K972011	OPUS ETHANOL	DIC	1997-07-22	View
510(k)	K971596	EMIT II OPIATES 300/2000 ASSAY	DJG	1997-06-25	View
510(k)	K971600	EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)	DKB	1997-06-25	View
510(k)	K964595	OPUS PSA TEST SYSTEM	LTJ	1997-06-24	View
510(k)	K971725	OPUS PROGESTERONE	JLS	1997-06-18	View
510(k)	K970645	BC THROMBIN REAGENT	GJA	1997-05-19	View
510(k)	K970431	BEHRING COAGULATION SYSTEM	JPA	1997-05-05	View
510(k)	K964764	OPUS BONE ALP	CIN	1997-01-24	View
510(k)	K964527	N RHEUMATOLOGY STANDARD SL	JIX	1997-01-15	View
510(k)	K964687	N LATEX CRP MONO REAGENT	DCH	1996-12-16	View
510(k)	K962968	PROC APC ASSAY, PROC CONTROL PLASMA	GGP	1996-12-13	View
510(k)	K964062	N PROTEIN STRANDARD SL	JIX	1996-11-21	View
510(k)	K964065	N/T PROTEIN CONTROL SL	JJY	1996-11-06	View
510(k)	K963084	OPUS CMV TEST SYSTEM-MODIFICATION	LFZ	1996-10-09	View