Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
159 devices
Cleared
Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
Chemistry
12d
Cleared
Aug 31, 2000
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
Chemistry
21d
Cleared
Aug 30, 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
Chemistry
14d
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
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
Apr 27, 1999
ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10
Chemistry
62d
Cleared
Apr 09, 1999
MICROPLATE NEONATAL GALT ASSAY
Chemistry
28d
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
Cleared
Mar 09, 1999
ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
Chemistry
39d
Cleared
Feb 02, 1999
LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
Chemistry
36d
Cleared
Feb 02, 1999
ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05
Chemistry
36d
Cleared
Feb 02, 1999
ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05
Chemistry
36d
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