Bio-Rad - FDA 510(k) Cleared Devices
319
Total
319
Cleared
0
Denied
319 devices
Cleared
Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS,...
Immunology
15d
Cleared
Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS...
Chemistry
15d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
Chemistry
27d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
Chemistry
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS...
Chemistry
26d
Cleared
May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS...
Chemistry
26d
Cleared
May 24, 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
Chemistry
15d
Cleared
Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
Chemistry
56d
Cleared
Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
Hematology
28d
Cleared
Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2,...
Hematology
34d
Cleared
Sep 12, 2001
LIQUICHEK TDM CONTROL
Chemistry
27d
Cleared
Sep 06, 2001
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
Chemistry
24d
Cleared
Aug 29, 2001
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS...
Chemistry
23d
Cleared
Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
Immunology
34d
Cleared
Jul 12, 2001
LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600
Chemistry
28d
Cleared
Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
Immunology
35d
Cleared
Jun 08, 2001
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL...
Immunology
24d
Cleared
Dec 19, 2000
VARIANT II TOTAL GHB
Hematology
61d
Cleared
Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
Chemistry
44d
Cleared
Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
Chemistry
44d
Cleared
Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
Hematology
62d
Cleared
Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
Chemistry
12d
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
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