Boehringer Mannheim Corp. - FDA 510(k) Cleared Devices
340
Total
340
Cleared
0
Denied
245 devices
Cleared
Nov 12, 1997
ELECSYS FOLATE
Chemistry
47d
Cleared
Nov 04, 1997
ELECSYS CALLCHECK DIGOXIN
Chemistry
15d
Cleared
Oct 09, 1997
GLUCOTREND BASIC SYSTEM
Chemistry
66d
Cleared
Oct 06, 1997
MYOGLOBIN CONTROL SET
Chemistry
28d
Cleared
Jul 07, 1997
PRECINORM TDM CONTROLS
Chemistry
105d
Cleared
Apr 02, 1997
THE ELECSYS CALCHECK PROGESTERONE
Chemistry
16d
Cleared
Mar 24, 1997
ELECSYS PROGESTERONE ASSAY
Chemistry
111d
Cleared
Mar 18, 1997
ELECSYS TESTOSTERONE ASSAY
Chemistry
102d
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
Cleared
Jan 30, 1997
ELECSYS CALCHECK TESTOSTERONE
Chemistry
15d
Cleared
Jan 24, 1997
ELECSYS LH ASSAY
Chemistry
63d
Cleared
Jan 21, 1997
ELECSYS PROLACTIN ASSAY
Chemistry
56d
Cleared
Dec 16, 1996
ELECSYS FT3
Chemistry
126d
Cleared
Dec 16, 1996
ELECSYS FSH ASSAY
Chemistry
24d
Cleared
Dec 16, 1996
ELECSYS CALCHECK FSH
Chemistry
14d
Cleared
Dec 16, 1996
ELECSYS CALCHECK LH
Chemistry
14d
Cleared
Nov 29, 1996
ENZYMUN-TEST FT3
Chemistry
136d
Cleared
Oct 23, 1996
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
Chemistry
68d
Cleared
Sep 10, 1996
ELECSYS CALCHECK T UPDATE
Chemistry
27d
Cleared
Aug 30, 1996
ELECSYS CALCHECK HCG
Chemistry
16d
Cleared
Aug 27, 1996
ELECSYS CALCHECK FT3
Chemistry
13d
Cleared
Aug 27, 1996
ELECSYS CALCHECK FT4
Chemistry
13d
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