Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bio-Rad — Predicate Candidate Screening

319 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

39 daysmedian FDA review time

138 days90th percentile

319clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K171061	MRSASelect II	Bio-Rad	2017-12-28	262	0
K122187	VRESELECT CULTURE MEDIUM	Bio-Rad	2012-11-06	105	0
K103684	VRESELECT CULTURE MEDIUM	Bio-Rad	2011-10-21	308	0
K093678	PLATELIA ASPERGILLUS EIA MODEL 62793	Bio-Rad	2011-01-13	412	0
K100589	MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS	Bio-Rad	2010-10-29	241	0
K081362	PLATELIA LYME IGM	Bio-Rad	2008-06-26	42	0
K081212	MRSASELECT - EXTENDED INCUBATION	Bio-Rad	2008-06-13	45	0
K080012	PLATELIA LYME IGG ASSAY	Bio-Rad	2008-05-08	126	0
K070361	MRSASELECT	Bio-Rad	2007-09-13	218	0
K060641	PLATELIA ASPERGILLUS EIA, MODEL 62793	Bio-Rad	2006-06-02	84	0
K052838	LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4	Bio-Rad	2005-11-09	33	0
K052053	LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, PO	Bio-Rad	2005-08-09	11	0
K050537	LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MA	Bio-Rad	2005-04-27	56	0
K050536	QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL	Bio-Rad	2005-03-24	22	0
K043208	LIQUID ASSAYED MULTIQUAL CONTROL	Bio-Rad	2005-01-07	49	0
K042865	LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)	Bio-Rad	2004-11-24	37	0
K042815	QUEST TUMOR MARKER CONTROL, MODEL 955	Bio-Rad	2004-11-05	24	0
K042836	LIQUICHEK RETICULOCYTE CONTROL (A)	Bio-Rad	2004-11-05	22	0
K042837	LIQUICHEK ELEVATED CRP CONTROL	Bio-Rad	2004-11-02	19	0
K042324	LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5	Bio-Rad	2004-10-07	41	0
K041561	LIQUICHEK WHOLE BLOOD VOLATILES CONTROL	Bio-Rad	2004-07-06	26	0
K041457	LIQUICHEK HEMATOLOGY CONTROL (A)	Bio-Rad	2004-06-28	27	0
K040275	LYPHOCHEK HEMOSTASIS CONTROL	Bio-Rad	2004-02-27	22	0
K033366	LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MO	Bio-Rad	2003-12-12	52	0
K033404	LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES)	Bio-Rad	2003-12-12	49	0
K033387	QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 94	Bio-Rad	2003-12-02	40	0
K032611	LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743	Bio-Rad	2003-09-17	23	0
K032017	LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3	Bio-Rad	2003-08-08	39	0
K031231	LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK	Bio-Rad	2003-06-18	61	0
K023857	PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794	Bio-Rad	2003-05-16	177	1
K030182	LIQUICHEK D-DIMER CONTROL, MODEL 356, 357	Bio-Rad	2003-02-24	38	0
K024218	LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114	Bio-Rad	2003-01-17	25	0
K024220	LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130	Bio-Rad	2003-01-17	25	0
K024232	LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113	Bio-Rad	2003-01-17	25	0
K024222	LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG	Bio-Rad	2003-01-15	23	0
K024217	LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #	Bio-Rad	2003-01-15	23	0
K024224	LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129	Bio-Rad	2003-01-15	23	0
K024227	LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127	Bio-Rad	2003-01-15	23	0
K024225	LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119	Bio-Rad	2003-01-15	23	0
K024229	LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG	Bio-Rad	2003-01-15	23	0
K024230	LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED,	Bio-Rad	2003-01-15	23	0
K024221	LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE,	Bio-Rad	2003-01-15	23	0
K024219	LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115	Bio-Rad	2003-01-15	23	0
K024231	LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CA	Bio-Rad	2003-01-13	21	0
K024223	LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116	Bio-Rad	2003-01-13	21	0
K024226	LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116	Bio-Rad	2003-01-10	18	0
K013839	BIO-RAD PLATELIA TOXO IGG TMB	Bio-Rad	2002-09-30	315	0
K013837	BIO-RAD PLATELIA TOXO IGM TMB	Bio-Rad	2002-09-30	315	0
K022991	LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 5	Bio-Rad	2002-09-17	8	0
K022707	LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEV	Bio-Rad	2002-08-22	8	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda