Medical Device Manufacturer · US , Chaska , MN

Bio-Rad Laboratories, Inc. - FDA 510(k) Cleared Devices

82 submissions · 82 cleared · Since 1991
82
Total
82
Cleared
0
Denied
82 devices
26-50 of 82
Cleared Dec 20, 2004
BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM,...
K041658 · LKJ
Immunology · 185d
Cleared Dec 07, 2004
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
K043108 · JJY
Immunology · 28d
Cleared Nov 02, 2004
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · JJW
Chemistry · 54d
Cleared Oct 14, 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · JPK
Hematology · 45d
Cleared Sep 17, 2004
ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05
K042335 · JJY
Immunology · 18d
Cleared Jun 09, 2004
BIO-RAD D-10 DUAL PROGRAM
K041444 · LCP
Chemistry · 8d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822 · JJY
Microbiology · 50d
Cleared Apr 15, 2004
VARIANT II HEMOGLOBIN A1C
K040872 · LCP
Chemistry · 13d
Cleared Mar 10, 2004
LIQUICHEK CARDIAC MARKER CONTROL LT
K040277 · JJY
Chemistry · 34d
Cleared Mar 04, 2004
LYPHOCHEK ASSAYED CHEMISTRY CONTROL
K040273 · JJY
Chemistry · 28d
Cleared Feb 03, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
K033924 · DIF
Chemistry · 47d
Cleared Aug 27, 2003
D-10 HEMOGLOBIN A1C
K031043 · LCP
Chemistry · 148d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · JJY
Immunology · 22d
Cleared Apr 12, 2002
LIQUICHEK URINE CHEMISTRY CONTROL
K020817 · JJY
Chemistry · 30d
Cleared Feb 25, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126 · CHP
Chemistry · 42d
Cleared Feb 04, 1997
ACCESS CHLAMYDIA ASSAY
K960850 · LJC
Microbiology · 340d
Cleared Dec 16, 1996
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS:...
K963934 · MMI
Chemistry · 76d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687 · LFX
Microbiology · 181d
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913 · CDP
Chemistry · 23d
Cleared Feb 05, 1996
ACCESS PROGESTERONE ASSAY
K955769 · JLS
Chemistry · 46d
Cleared Jan 24, 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435 · CDP
Chemistry · 114d
Cleared Jan 24, 1996
ACCESS VITAMIN B12 ASSAY (MODIFICATION)
K955436 · CDD
Chemistry · 114d
Cleared Dec 20, 1995
ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
K951495 · LGD
Microbiology · 264d
Cleared Dec 05, 1995
ACCESS CORTISOL ASSAY (MODIFICATION)
K954733 · CGR
Chemistry · 64d
Cleared Nov 21, 1995
ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K954825 · JLW
Chemistry · 32d

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