Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
319 devices
Cleared
Aug 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
Chemistry
14d
Cleared
Aug 21, 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
Chemistry
39d
Cleared
Aug 07, 2000
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
Chemistry
18d
Cleared
May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
Chemistry
24d
Cleared
Apr 20, 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
Chemistry
31d
Cleared
Apr 18, 2000
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
Chemistry
29d
Cleared
Apr 05, 2000
ARCHITECH AFP MASTERCHECK, MODEL 6C01-05
Immunology
230d
Cleared
Dec 21, 1999
BIO-RAD HOMOCYSTEINE BY HPLC
Toxicology
95d
Cleared
Nov 09, 1999
LYPHOCHEK ANEMIA CONTROL, MODEL 500
Immunology
85d
Cleared
Nov 04, 1999
BIO-RAD CODA NEONATAL GALT ASSAY
Chemistry
16d
Cleared
Sep 02, 1999
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
Chemistry
66d
Cleared
Aug 11, 1999
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
Chemistry
12d
Cleared
Jun 10, 1999
VARIANT II B-THALASSEMIA
Hematology
69d
Cleared
Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
Chemistry
62d
Cleared
Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
Hematology
37d
Cleared
Apr 16, 1999
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
Toxicology
28d
Cleared
Apr 09, 1999
MICROPLATE NEONATAL GALT ASSAY
Chemistry
28d
Cleared
Apr 07, 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
Immunology
43d
Cleared
Apr 07, 1999
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752
Chemistry
28d
Cleared
Mar 31, 1999
ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01
Chemistry
48d
Cleared
Mar 30, 1999
ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05
Chemistry
34d
Cleared
Mar 22, 1999
ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05
Chemistry
41d
Cleared
Mar 18, 1999
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
Chemistry
48d
Cleared
Mar 18, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
Chemistry
37d
Cleared
Mar 15, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
Chemistry
34d
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