Medical Device Manufacturer · US , Mchenry , IL

Bio-Rad

319 submissions · 319 cleared · Since 1976
319
Total
319
Cleared
0
Denied

Bio-Rad — FDA 510(k) Submissions

Bio-Rad has submitted 319 FDA 510(k) premarket notifications since 1976, of which 319 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Drug Mixture Control Materials, Single (specified) Analyte Controls (assayed And Unassayed), Assay, Glycosylated Hemoglobin, Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control . Use the specialty filter in the sidebar to narrow results.

319 devices
1–25 of 319
MRSASelect II
K171061 · JSO Culture Media,... · Microbiology
Dec 2017 262d
VRESELECT CULTURE MEDIUM
K122187 · JSO Culture Media,... · Microbiology
Nov 2012 105d
VRESELECT CULTURE MEDIUM
K103684 · JSO Culture Media,... · Microbiology
Oct 2011 308d
PLATELIA ASPERGILLUS EIA MODEL 62793
K093678 · NOM Antigen, Galactomannan,... · Microbiology
Jan 2011 412d
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
K100589 · JSO Culture Media,... · Microbiology
Oct 2010 241d
PLATELIA LYME IGM
K081362 · LSR Reagent, Borrelia... · Microbiology
Jun 2008 42d
MRSASELECT - EXTENDED INCUBATION
K081212 · JSO Culture Media,... · Microbiology
Jun 2008 45d
PLATELIA LYME IGG ASSAY
K080012 · LSR Reagent, Borrelia... · Microbiology
May 2008 126d
MRSASELECT
K070361 · JSO Culture Media,... · Microbiology
Sep 2007 218d
PLATELIA ASPERGILLUS EIA, MODEL 62793
K060641 · NOM Antigen, Galactomannan,... · Microbiology
Jun 2006 84d
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · GGM Control, Hemoglobin · Chemistry
Nov 2005 33d
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · DIF Drug Mixture Control... · Toxicology
Aug 2005 11d
LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS
K050537 · JJY Multi-analyte Controls,... · Chemistry
Apr 2005 56d
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
K050536 · JJY Multi-analyte Controls,... · Chemistry
Mar 2005 22d
LIQUID ASSAYED MULTIQUAL CONTROL
K043208 · JJY Multi-analyte Controls,... · Chemistry
Jan 2005 49d
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · DIF Drug Mixture Control... · Chemistry
Nov 2004 37d
QUEST TUMOR MARKER CONTROL, MODEL 955
K042815 · JJY Multi-analyte Controls,... · Immunology
Nov 2004 24d
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · JPK Mixture, Hematology... · Hematology
Nov 2004 22d
LIQUICHEK ELEVATED CRP CONTROL
K042837 · JJX Single (specified)... · Chemistry
Nov 2004 19d
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
K042324 · JJY Multi-analyte Controls,... · Chemistry
Oct 2004 41d
LIQUICHEK WHOLE BLOOD VOLATILES CONTROL
K041561 · DIF Drug Mixture Control... · Chemistry
Jul 2004 26d
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · JPK Mixture, Hematology... · Hematology
Jun 2004 27d
LYPHOCHEK HEMOSTASIS CONTROL
K040275 · GGN Plasma, Coagulation Control · Hematology
Feb 2004 22d
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455
K033366 · DIF Drug Mixture Control... · Toxicology
Dec 2003 52d
LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)
K033404 · DIF Drug Mixture Control... · Toxicology
Dec 2003 49d

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