Boehringer Mannheim Corp.

Mchenry, IL, US

Boehringer Mannheim Corp. appears in FDA device records in Mchenry, IL. FDA records list 340 510(k) clearances between 1976-10-08 and 1999-02-08, 5 PMA records and no registered establishments. As of 2026-09-10, FDA records show no recalls for this company.

510(k) clearances: 340
PMA records: 5
Recall records: 0
Registered establishments: 0

510(k) clearance history

Showing 50 of 340

FDA records hold 340 510(k) clearances for Boehringer Mannheim Corp. between 1976 and 1999. The busiest year on record is 1996, with 46. The most recent is 1999, with 4.

Clearances by year, as a table

510(k) clearance decisions for Boehringer Mannheim Corp., by decision year
Year	Clearances
1976	4
1977	9
1978	11
1979	7
1980	5
1981	13
1982	13
1983	5
1984	8
1985	12
1986	20
1987	20
1988	7
1989	8
1990	28
1991	12
1992	5
1993	8
1994	6
1995	14
1996	46
1997	40
1998	35
1999	4

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K984326	ELECYS IGE ASSAY	JHR	Substantially Equivalent	1999-02-08
K983047	ACCU-CHEK HQ SYSTEM	LFR	Substantially Equivalent	1999-02-05
K984419	ELECSYS IGE CALCHECK	JJY	Substantially Equivalent	1999-02-02
K984425	MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR	JIX	Substantially Equivalent	1999-01-20
K984372	ELECSYS CALCHECK TROPONIN T	JJY	Substantially Equivalent	1998-12-14
K984105	ELECSYS TROPONIN T STAT TEST	MMI	Substantially Equivalent	1998-12-08
K983503	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347	CEO	Substantially Equivalent	1998-12-01
K983469	PRECISET SERUM PROTEINS CALIBRATOR	JIX	Substantially Equivalent	1998-11-25
K983185	BOEHRINGER MANNHEIM TINA-QUANT IGE TEST	DGC	Substantially Equivalent	1998-11-12
K983510	CHEMSTRIP 101 URINE ANALYZER	KQO	Substantially Equivalent	1998-10-27
K982949	ELECSYS PSA, MODEL 2010	LTJ	Substantially Equivalent	1998-10-27
K982948	ELECSYS PSA, MODEL # ELECSYS 1010	LTJ	Substantially Equivalent	1998-10-27
K983416	ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353	JGJ	Substantially Equivalent	1998-10-21
K980724	TINAQUANT B 2-MICROGLOBULIN ASSAY	JZG	Substantially Equivalent	1998-10-16
K983492	BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC	JJY	Substantially Equivalent	1998-10-09
K983176	ELECSYS MYOGLOBIN STAT ASSAY	DDR	Substantially Equivalent	1998-09-24
K983166	ELECSYS CALCHECK MYOGLOBIN	JJY	Substantially Equivalent	1998-09-22
K982089	ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS	LFR	Substantially Equivalent	1998-09-03
K982002	ACCU-CHEK COMFORT CURVE TEST STRIP	LFR	Substantially Equivalent	1998-09-02
K982079	ACCU-CHECK VOICEMATE	LFR	Substantially Equivalent	1998-08-28
K982471	B2-MICROGLOBULIN CONTROL SET SERUM	JJX	Substantially Equivalent	1998-08-06
K981883	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844	CIG	Substantially Equivalent	1998-07-07
K980887	ELECSYS CEA ON THE ELECSYS 1010	DHX	Substantially Equivalent	1998-06-29
K980746	CEDIA DAU EDDP ASSAY	DJR	Substantially Equivalent	1998-05-26
K980731	ACCU-CHEK COMFORT CURVE TEST STRIPS	LFR	Substantially Equivalent	1998-05-22
K981401	BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS	JJY	Substantially Equivalent	1998-05-18
K974491	ACCU-CHEK A1C HEMOGLOBIN TEST	LCP	Substantially Equivalent	1998-05-13
K980853	CEDIA DAU MULTI-DRUG CALIBRATORS	DKB	Substantially Equivalent	1998-04-21
K980240	ELECSYS CA 125II ON THE ELECSYS 1010	LTK	Substantially Equivalent	1998-03-25
K972162	ELECSYS CA 125 II	LTK	Substantially Equivalent	1998-03-18
K973523	ACCUSTAT H. PYLORI ONE STEP TEST	LYR	Substantially Equivalent	1998-03-03
K974825	BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS	JIX	Substantially Equivalent	1998-01-30
K974733	BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL	LBR	Substantially Equivalent	1998-01-26
K974826	BM PRECIPATH(R) HDL/LDL-C CONTROL	JJY	Substantially Equivalent	1998-01-22
K974569	COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING	JPA	Substantially Equivalent	1998-01-09
K972640	TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY	DEM	Substantially Equivalent	1998-01-09
K972639	TINA-QUANT HAPTOGLOBIN	DAD	Substantially Equivalent	1998-01-09
K972638	TINA-QUANT PREALBUMIN	JZJ	Substantially Equivalent	1998-01-09
K974189	ELECSYS PSA (ON ELECSYS 1010)	LTJ	Substantially Equivalent	1998-01-06
K974421	ELECSYS CK-MB STAT	JHY	Substantially Equivalent	1997-12-17
K973662	ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS	LFR	Substantially Equivalent	1997-12-15
K974384	ELECSYS CALCHECK FOLATE	JJY	Substantially Equivalent	1997-12-08
K974383	ELECSYS CALCHECK VITAMIN B12	JJX	Substantially Equivalent	1997-12-08
K973351	ELECSYS AFP	LOJ	Substantially Equivalent	1997-11-21
K973702	ELECSYS VITAMIN B12 ASSAY	CDD	Substantially Equivalent	1997-11-13
K973674	ELECSYS FOLATE	CDD	Substantially Equivalent	1997-11-12
K973973	ELECSYS CALLCHECK DIGOXIN	DMP	Substantially Equivalent	1997-11-04
K973112	ELECSYS DIGOXIN	KXT	Substantially Equivalent	1997-10-10
K972876	GLUCOTREND BASIC SYSTEM	LFR	Substantially Equivalent	1997-10-09
K973629	PRECINORM RF, PRECIPATH RF	JJY	Substantially Equivalent	1997-10-07

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain