Company ยท US
Bio-Rad
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2017. Name variants (Inc, Corp, punctuation) are merged.
319510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 61 |
| DIF | Drug Mixture Control Materials | 31 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 21 |
| LCP | Assay, Glycosylated Hemoglobin | 15 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 14 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 9 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 9 |
| LKJ | Antinuclear Antibody, Antigen, Control | 9 |
| GGN | Plasma, Coagulation Control | 7 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 6 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 6 |
| CGN | Acid, Folic, Radioimmunoassay | 5 |
| HKX | Tonometer, Ac-Powered | 5 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 5 |
| CDX | Radioimmunoassay, Total Thyroxine | 4 |
| CGI | Radioimmunoassay, Estriol | 4 |
| JPD | Hemoglobin A2 Quantitation | 4 |
| CDD | Radioassay, Vitamin B12 | 3 |
| CDF | Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 28, 2017 | K171061 | MRSASelect II Bio-Rad, FR | JSO |
| Nov 6, 2012 | K122187 | VRESELECT CULTURE MEDIUM Bio-Rad | JSO |
| Oct 21, 2011 | K103684 | VRESELECT CULTURE MEDIUM Bio-Rad | JSO |
| Jan 13, 2011 | K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 Bio-Rad | NOM |
| Oct 29, 2010 | K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS Bio-Rad | JSO |
| Jun 26, 2008 | K081362 | PLATELIA LYME IGM Bio-Rad | LSR |
| Jun 13, 2008 | K081212 | MRSASELECT - EXTENDED INCUBATION Bio-Rad | JSO |
| May 8, 2008 | K080012 | PLATELIA LYME IGG ASSAY Bio-Rad | LSR |
| Sep 13, 2007 | K070361 | MRSASELECT Bio-Rad | JSO |
| Jun 2, 2006 | K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 Bio-Rad | NOM |
| Nov 9, 2005 | K052838 | LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 Bio-Rad | GGM |
| Aug 9, 2005 | K052053 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK Bio-Rad | DIF |
| Apr 27, 2005 | K050537 | LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS Bio-Rad | JJY |
| Mar 24, 2005 | K050536 | QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL Bio-Rad | JJY |
| Jan 7, 2005 | K043208 | LIQUID ASSAYED MULTIQUAL CONTROL Bio-Rad | JJY |
| Nov 24, 2004 | K042865 | LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) Bio-Rad | DIF |
| Nov 5, 2004 | K042836 | LIQUICHEK RETICULOCYTE CONTROL (A) Bio-Rad | JPK |
| Nov 5, 2004 | K042815 | QUEST TUMOR MARKER CONTROL, MODEL 955 Bio-Rad | JJY |
| Nov 2, 2004 | K042837 | LIQUICHEK ELEVATED CRP CONTROL Bio-Rad | JJX |
| Oct 7, 2004 | K042324 | LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 Bio-Rad | JJY |
| Jul 6, 2004 | K041561 | LIQUICHEK WHOLE BLOOD VOLATILES CONTROL Bio-Rad | DIF |
| Jun 28, 2004 | K041457 | LIQUICHEK HEMATOLOGY CONTROL (A) Bio-Rad | JPK |
| Feb 27, 2004 | K040275 | LYPHOCHEK HEMOSTASIS CONTROL Bio-Rad | GGN |
| Dec 12, 2003 | K033404 | LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) Bio-Rad | DIF |
| Dec 12, 2003 | K033366 | LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 Bio-Rad | DIF |
| Dec 2, 2003 | K033387 | QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 Bio-Rad | JJY |
| Sep 17, 2003 | K032611 | LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 Bio-Rad | GGN |
| Aug 8, 2003 | K032017 | LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 Bio-Rad | GGN |
| Jun 18, 2003 | K031231 | LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS Bio-Rad | JJW |
| May 16, 2003 | K023857 | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 Bio-Rad | NOM |
| Feb 24, 2003 | K030182 | LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 Bio-Rad | GGN |
| Jan 17, 2003 | K024232 | LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 Bio-Rad | LKJ |
| Jan 17, 2003 | K024220 | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 Bio-Rad | DHN |
| Jan 17, 2003 | K024218 | LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 Bio-Rad | LKJ |
| Jan 15, 2003 | K024230 | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 Bio-Rad | DHN |
| Jan 15, 2003 | K024229 | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 Bio-Rad | DHN |
| Jan 15, 2003 | K024227 | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 Bio-Rad | DHN |
| Jan 15, 2003 | K024225 | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 Bio-Rad | DHN |
| Jan 15, 2003 | K024224 | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 Bio-Rad | DHN |
| Jan 15, 2003 | K024222 | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 Bio-Rad | DHN |
| Jan 15, 2003 | K024221 | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 Bio-Rad | DHN |
| Jan 15, 2003 | K024219 | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 Bio-Rad | LKP |
| Jan 15, 2003 | K024217 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 Bio-Rad | DHN |
| Jan 13, 2003 | K024231 | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 Bio-Rad | DHN |
| Jan 13, 2003 | K024223 | LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 Bio-Rad | LKJ |
| Jan 10, 2003 | K024226 | LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 Bio-Rad | LKJ |
| Sep 30, 2002 | K013839 | BIO-RAD PLATELIA TOXO IGG TMB Bio-Rad | LGD |
| Sep 30, 2002 | K013837 | BIO-RAD PLATELIA TOXO IGM TMB Bio-Rad | LGD |
| Sep 17, 2002 | K022991 | LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 596 Bio-Rad | JJY |
| Aug 22, 2002 | K022707 | LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439 Bio-Rad | DIF |
Newest 50 of 319.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||