Boehringer Mannheim Corp.

FDA 510(k) & PMA Approved Devices — 340 products

Total Devices340

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K984326	ELECYS IGE ASSAY	JHR	1999-02-08	View
510(k)	K983047	ACCU-CHEK HQ SYSTEM	LFR	1999-02-05	View
510(k)	K984419	ELECSYS IGE CALCHECK	JJY	1999-02-02	View
510(k)	K984425	MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR	JIX	1999-01-20	View
510(k)	K984372	ELECSYS CALCHECK TROPONIN T	JJY	1998-12-14	View
510(k)	K984105	ELECSYS TROPONIN T STAT TEST	MMI	1998-12-08	View
510(k)	K983503	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347	CEO	1998-12-01	View
510(k)	K983469	PRECISET SERUM PROTEINS CALIBRATOR	JIX	1998-11-25	View
510(k)	K983185	BOEHRINGER MANNHEIM TINA-QUANT IGE TEST	DGC	1998-11-12	View
510(k)	K983510	CHEMSTRIP 101 URINE ANALYZER	KQO	1998-10-27	View
510(k)	K982948	ELECSYS PSA, MODEL # ELECSYS 1010	LTJ	1998-10-27	View
510(k)	K982949	ELECSYS PSA, MODEL 2010	LTJ	1998-10-27	View
510(k)	K983416	ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353	JGJ	1998-10-21	View
510(k)	K980724	TINAQUANT B 2-MICROGLOBULIN ASSAY	JZG	1998-10-16	View
510(k)	K983492	BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC	JJY	1998-10-09	View
510(k)	K983176	ELECSYS MYOGLOBIN STAT ASSAY	DDR	1998-09-24	View
510(k)	K983166	ELECSYS CALCHECK MYOGLOBIN	JJY	1998-09-22	View
510(k)	K982089	ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS	LFR	1998-09-03	View
510(k)	K982002	ACCU-CHEK COMFORT CURVE TEST STRIP	LFR	1998-09-02	View
510(k)	K982079	ACCU-CHECK VOICEMATE	LFR	1998-08-28	View