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

Orion Diagnostica, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time

236 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K942286	DIARLEX ROTA-ADENO	Orion Diagnostica, Inc.	1994-12-14	236
K914892	SALIVA-STIM	Orion Diagnostica, Inc.	1992-09-02	307
K904655	PYLORISET	Orion Diagnostica, Inc.	1991-10-21	374
K884147	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M	Orion Diagnostica, Inc.	1988-10-27	24
K884074	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G	Orion Diagnostica, Inc.	1988-10-27	30
K884040	IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A	Orion Diagnostica, Inc.	1988-10-19	23
K884075	IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN	Orion Diagnostica, Inc.	1988-10-19	22
K864645	ADENOLEX (R) LATEX AGGLUTINATION TEST	Orion Diagnostica, Inc.	1987-06-04	191
K871196	RHEUMA-CHECK ENZYME IMMUNOASSAY TEST	Orion Diagnostica, Inc.	1987-05-06	43
K862475	RESPIRASTICK ENZYME IMMUNOASSAY TEST	Orion Diagnostica, Inc.	1986-09-16	78
K854129	ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS	Orion Diagnostica, Inc.	1986-01-21	104
K844399	RESPIRALEX LATEX AGGLUTINATION TEST	Orion Diagnostica, Inc.	1985-01-08	56
K841319	ROTALEX LATEX AGGLUTINATION TEST	Orion Diagnostica, Inc.	1984-09-14	165
K831124	BIOCULT - GC CULTURE-PADDLES	Orion Diagnostica, Inc.	1983-05-09	34
K821659	RESPIRACULT-STREP DEEP BED CULTURE PAD	Orion Diagnostica, Inc.	1982-08-05	62
K802931	INFLUENZA A & B S-ANTIGEN & CONTROLS	Orion Diagnostica, Inc.	1981-01-12	54
K802930	CYTOMEGALO VIRUS & CONTROLS	Orion Diagnostica, Inc.	1981-01-09	51
K802932	MEASLES VIRUS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802933	MUMPS S & V ANTIGENS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802939	HERPES SIMPLEX TYPE I	Orion Diagnostica, Inc.	1980-12-31	42
K802936	RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &	Orion Diagnostica, Inc.	1980-12-31	42
K802935	PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR	Orion Diagnostica, Inc.	1980-12-31	42
K802937	RUBELLA VIRUS ANTIGENS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802929	ADENO VIRUS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802934	MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL	Orion Diagnostica, Inc.	1980-12-31	42
K802938	VARICELLA-ZOSTER ANTIGENS & CONTROLS	Orion Diagnostica, Inc.	1980-12-31	42
K802946	MYCOLOGY CULTURE SYSTEM	Orion Diagnostica, Inc.	1980-12-22	33
K802947	ORICULT DTM	Orion Diagnostica, Inc.	1980-12-22	33

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