Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Oct 26, 1995
CHEMSTRIP MICRAL URINE TEST STRIPS
Chemistry
38d
Cleared
Oct 23, 1995
CHEMSTRIP CRITERION URINE ANALYZER
Chemistry
56d
Cleared
Sep 25, 1995
BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER
Chemistry
76d
Cleared
Aug 24, 1995
ADVANTAGE TEST STRIPS
Chemistry
122d
Cleared
Aug 11, 1995
ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR
Chemistry
140d
Cleared
Jul 20, 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
Chemistry
73d
Cleared
Feb 10, 1995
TINA-QUANT MICROALBUMIN
Chemistry
603d
Cleared
Dec 05, 1994
BOEHRINGER MANNHEIM BICARBONATE ASSAY
Chemistry
507d
Cleared
Nov 08, 1994
CHEMSTRIP MINI UA URINE ANALYZER
Chemistry
106d
Cleared
Oct 04, 1994
HITACHI 914 ANALYZER
Chemistry
140d
Cleared
Apr 26, 1994
CARDIAC T ELISA TROPONIN-T
Chemistry
603d
Cleared
Nov 17, 1993
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
Chemistry
162d
Cleared
Oct 14, 1993
CHEMSTRIP SUPER UA URINE ANALYZER
Chemistry
56d
Cleared
Sep 08, 1993
ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
Chemistry
195d
Cleared
Jun 15, 1993
CHEMSTRIP URINE ANALYZER
Chemistry
75d
Cleared
Oct 14, 1992
ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
Chemistry
112d
Cleared
Oct 13, 1992
ACCUDATA GLUCOSE TEST STATION
Chemistry
40d
Cleared
Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
Chemistry
84d
Cleared
Mar 24, 1992
CHEMSTRIP URINE ANALYZER
Chemistry
18d
Cleared
Feb 14, 1992
ENZYMUN-TEST TSH
Chemistry
87d
Cleared
Dec 09, 1991
CEDIA T4
Chemistry
20d
Cleared
Sep 27, 1991
ENZYMUN-TEST ESTRADIOL
Chemistry
72d
Cleared
Sep 13, 1991
URINARY/CSF PROTEIN
Chemistry
31d
Cleared
Aug 28, 1991
PROACT CHOLESTEROL SYSTEMS
Chemistry
100d
Cleared
Aug 12, 1991
REFLOTRON CREATININE TEST TABS
Chemistry
31d
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