Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
340 devices
Cleared
Oct 06, 1997
MYOGLOBIN CONTROL SET
Chemistry
28d
Cleared
Sep 22, 1997
MODIFIED CEDIA DAU PCP ASSAY
Toxicology
42d
Cleared
Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
Immunology
57d
Cleared
Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
Immunology
275d
Cleared
Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
Immunology
21d
Cleared
Jul 25, 1997
ELECSYS PSA ASSAY
Immunology
266d
Cleared
Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
Toxicology
24d
Cleared
Jul 07, 1997
PRECINORM TDM CONTROLS
Chemistry
105d
Cleared
Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
Immunology
64d
Cleared
Jun 16, 1997
ELECSYS CEA ASSAY
Immunology
227d
Cleared
Jun 02, 1997
ELECSYS FERRITIN
Immunology
14d
Cleared
May 21, 1997
CEDIA DIGOXIN II
Toxicology
72d
Cleared
May 14, 1997
CEDIA DIGOXIN
Toxicology
65d
Cleared
Apr 22, 1997
COAGUCHEK PST SYSTEM
Hematology
295d
Cleared
Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
Chemistry
16d
Cleared
Mar 24, 1997
ELECSYS PROGESTERONE ASSAY
Chemistry
111d
Cleared
Mar 19, 1997
ENZYMUN-TEST PSA
Immunology
90d
Cleared
Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
Chemistry
102d
Cleared
Mar 06, 1997
ELECSYS CALCHECK CEA
Immunology
28d
Cleared
Mar 06, 1997
ELECSYS CALCHECK PSA
Immunology
28d
Cleared
Mar 06, 1997
ELECSYS CALCHECK CEA
Immunology
28d
Cleared
Feb 18, 1997
ELECSYS ESTRADIOL ASSAY
Chemistry
60d
Cleared
Feb 10, 1997
CARDIAC T TROPONIN T RAPID ASSAY
Chemistry
101d
Cleared
Feb 10, 1997
ELECSYS CALCHECK PROLACTIN
Chemistry
26d
Cleared
Feb 10, 1997
ELECSYS CALCHECK ESTRADIOL
Chemistry
26d
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