Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
May 18, 1998
BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
Chemistry
31d
Cleared
May 13, 1998
ACCU-CHEK A1C HEMOGLOBIN TEST
Hematology
166d
Cleared
Apr 21, 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
Toxicology
47d
Cleared
Mar 25, 1998
ELECSYS CA 125II ON THE ELECSYS 1010
Immunology
61d
Cleared
Mar 18, 1998
ELECSYS CA 125 II
Immunology
282d
Cleared
Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
Microbiology
167d
Cleared
Jan 30, 1998
BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS
Chemistry
37d
Cleared
Jan 26, 1998
BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL
Chemistry
39d
Cleared
Jan 22, 1998
BM PRECIPATH(R) HDL/LDL-C CONTROL
Chemistry
29d
Cleared
Jan 09, 1998
TINA-QUANT PREALBUMIN
Immunology
178d
Cleared
Jan 09, 1998
TINA-QUANT HAPTOGLOBIN
Immunology
178d
Cleared
Jan 09, 1998
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
Immunology
178d
Cleared
Jan 09, 1998
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING
Hematology
32d
Cleared
Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
Immunology
60d
Cleared
Dec 17, 1997
ELECSYS CK-MB STAT
Chemistry
23d
Cleared
Dec 15, 1997
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK...
Chemistry
81d
Cleared
Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
Chemistry
17d
Cleared
Dec 08, 1997
ELECSYS CALCHECK FOLATE
Chemistry
17d
Cleared
Nov 21, 1997
ELECSYS AFP
Immunology
77d
Cleared
Nov 13, 1997
ELECSYS VITAMIN B12 ASSAY
Chemistry
48d
Cleared
Nov 12, 1997
ELECSYS FOLATE
Chemistry
47d
Cleared
Nov 04, 1997
ELECSYS CALLCHECK DIGOXIN
Chemistry
15d
Cleared
Oct 10, 1997
ELECSYS DIGOXIN
Toxicology
51d
Cleared
Oct 09, 1997
GLUCOTREND BASIC SYSTEM
Chemistry
66d
Cleared
Oct 07, 1997
PRECINORM RF, PRECIPATH RF
Immunology
13d
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