Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
159 devices
Cleared
Jan 29, 1999
LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
Chemistry
44d
Cleared
Jan 29, 1999
ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5
Chemistry
32d
Cleared
Jan 28, 1999
ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01
Chemistry
9d
Cleared
Jan 28, 1999
ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01
Chemistry
9d
Cleared
Jan 26, 1999
ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01
Chemistry
7d
Cleared
Jan 26, 1999
ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01
Chemistry
7d
Cleared
Jan 25, 1999
ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10
Chemistry
21d
Cleared
Dec 22, 1998
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
Chemistry
19d
Cleared
Dec 22, 1998
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
Chemistry
19d
Cleared
Dec 15, 1998
ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
Chemistry
12d
Cleared
Dec 15, 1998
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
Chemistry
12d
Cleared
Dec 15, 1998
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
Chemistry
12d
Cleared
Dec 14, 1998
LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
Chemistry
19d
Cleared
Dec 03, 1998
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
Chemistry
17d
Cleared
Nov 25, 1998
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
Chemistry
9d
Cleared
Nov 25, 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
Chemistry
9d
Cleared
Nov 24, 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
Chemistry
8d
Cleared
Nov 20, 1998
ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
Chemistry
4d
Cleared
Nov 12, 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
Chemistry
30d
Cleared
May 12, 1998
LYPHOCHEK IMMUNOASSAY PLUS CONTROL
Chemistry
13d
Cleared
Feb 25, 1998
LIQUICHEK CARDIAC MARKERS CONTROL LT
Chemistry
12d
Cleared
Feb 09, 1998
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
Chemistry
157d
Cleared
Jul 30, 1997
CODA AUTOMATED EIA ANALYZER
Chemistry
58d
Cleared
Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
Chemistry
19d
Cleared
Jun 11, 1997
LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)
Chemistry
14d
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