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

LIQ — Predicate Candidate Screening

33 FDA 510(k) clearances under this product code; the 50 most recent screened below.

124 daysmedian FDA review time

276 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K990842	SAS ROTA TEST	Sa Scientific, Inc.	1999-08-09	147
K972895	VIDAS ROTAVIRUS (RTV) ASSAY	Biomerieux Vitek, Inc.	1997-10-03	59
K971585	IMMUNOCARD STAT! ROTAVIRUS	Meridian Diagnostics, Inc.	1997-08-20	111
K964424	ROTAVIRUS EIA	Trinity Biotech, Inc.	1997-08-08	276
K965092	VIDAS ROTAVIRUS ASSAY	Biomerieux Vitek, Inc.	1997-05-05	137
K951208	ROTA-DAN RAPID ROTAVIRUS EIA KIT	Eldan Technologies, Ltd.	1996-02-14	334
K942286	DIARLEX ROTA-ADENO	Orion Diagnostica, Inc.	1994-12-14	236
K933587	IMMUNOCARD ROTAVIRUS	Meridian Diagnostics, Inc.	1994-02-03	192
K932384	IDEIA(TM) ROTAVIRUS	Dako Diagnostics , Ltd.	1993-12-27	224
K915137	KALLESTAD ROTAVIRUS MICROPLATE	Bio-Rad Laboratories, Inc.	1992-03-04	112
K912666	DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440	Dako Corp.	1992-02-14	241
K895805	SLIDEX ROTA-KIT 2	Vitek Systems, Inc.	1991-02-26	516
K884017	ROTACUBE	Difco Laboratories, Inc.	1989-01-24	124
K883935	ORTHO* ROTAVIRUS ANTIGEN ELISA TEST	Ortho Diagnostic Systems, Inc.	1989-01-04	107
K883940	ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST	Ortho Diagnostic Systems, Inc.	1989-01-04	107
K880821	RESUBMITTED ABBOTT TESTPACK ROTAVIRUS	Abbott Laboratories	1988-05-06	66
K874375	ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL	Abbott Laboratories	1987-12-10	45
K873740	ROTASCREEN EIA	Mercia Diagnostics , Ltd.	1987-11-27	73
K864811	ROTA-STAT	Intl. Diagnostic Laboratories, Ltd.	1987-08-25	259
K861628	WELLCOZYME ROTAVIRUS WZ01	Wellcome Diagnostics	1987-01-21	267
K861634	THE WELLCOME ROTAVIRUS LATEX TEST ZL40	Wellcome Diagnostics	1986-10-29	183
K862917	PATHFINDER ROTAVIRUS CHEMILUMINESCENT	Kallestad Laboratories, Inc.	1986-10-22	82
K861172	ROTAVIRUS LATEX AGGLUTINATION ASSAY	Bartels Immunodiagnostic Supplies, Inc.	1986-07-01	95
K860529	ROTALEX	Orion Corp.	1986-03-04	21
K854129	ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS	Orion Diagnostica, Inc.	1986-01-21	104
K853554	PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS	Kallestad Laboratories, Inc.	1985-11-26	92
K853399	VIROGEN ROTATEST SLIDE TEST	Armkel, LLC	1985-11-12	92
K852969	ROTACLONE ROTAVIRUS DIAGNOSTIC KIT	Cambridge Bioscience Corp.	1985-11-05	113
K850269	MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE	Meridian Diagnostics, Inc.	1985-07-18	176
K843367	ROTAVIRUS ENZYME IMMUNOASSAY	Intl. Diagnostic Laboratories, Ltd.	1985-06-13	289
K841243	ENZYGNOST ROTAVIRUS AG	Behring Diagnostics, Inc.	1984-10-17	208
K841319	ROTALEX LATEX AGGLUTINATION TEST	Orion Diagnostica, Inc.	1984-09-14	165
K834443	ROTAVIRUS BIO-ENZABEAD SCREEN KIT	Litton Bionetics	1984-03-16	91

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