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

Syva Co. — Predicate Candidate Screening

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

35 daysmedian FDA review time

109 days90th percentile

448clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K011878	EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SA	Syva Co.	2001-08-13	59	0
K012257	EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MO	Syva Co.	2001-08-03	16	0
K011947	EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL	Syva Co.	2001-07-02	11	0
K011528	EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229	Syva Co.	2001-06-06	20	3
K011347	EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229	Syva Co.	2001-05-17	15	0
K993980	SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409U	Syva Co.	2000-02-01	69	0
K993981	SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL	Syva Co.	2000-02-01	69	0
K993987	SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL	Syva Co.	2000-01-27	64	0
K993983	SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL	Syva Co.	2000-01-27	64	0
K993028	ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1	Syva Co.	2000-01-27	140	0
K993982	SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/	Syva Co.	2000-01-27	64	0
K993026	ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALI	Syva Co.	2000-01-27	140	1
K993031	ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E	Syva Co.	2000-01-27	140	2
K993029	ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E	Syva Co.	2000-01-27	140	0
K993986	SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL	Syva Co.	2000-01-27	64	0
K993985	SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129	Syva Co.	2000-01-27	64	0
K993988	SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL	Syva Co.	2000-01-27	64	0
K994005	SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL	Syva Co.	2000-01-20	57	0
K993984	SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL	Syva Co.	2000-01-18	55	0
K993755	EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3,	Syva Co.	1999-12-21	46	0
K984232	MODIFICATION OF EMIT D.A.U. OPIATES ASSAY	Syva Co.	1999-01-22	58	0
K951755	EMIT 2000 DIGOXIN ASSAY	Syva Co.	1995-06-01	45	0
K935192	EMIT IIC CALIBRATORS	Syva Co.	1995-03-24	514	0
K935352	EMIT(R) IIC AMPHETAMINE ASSAY	Syva Co.	1995-02-22	474	0
K935191	EMIT IIC PHENCYCLIDINE ASSAY	Syva Co.	1995-02-22	484	0
K935323	EMIT IIC COCAINE METABOLITE ASSAY	Syva Co.	1995-02-22	475	0
K935116	EMIT IIC BARBITURATE ASSAY	Syva Co.	1995-02-22	483	0
K940158	EMIT IIC CANNABINOID ASSAY	Syva Co.	1995-02-22	406	0
K943500	EMIT 2000 DIGOXIN ASSAY	Syva Co.	1994-11-15	133	0
K942619	EMIT 2000 DIGOXIN ASSAY/CALIBRATORS	Syva Co.	1994-09-20	117	0
K941235	VISTA B12 ASSAY	Syva Co.	1994-08-15	153	0
K934135	EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION	Syva Co.	1994-04-06	224	0
K935117	EMIT(R) IIC OPIATE ASSAY	Syva Co.	1994-01-06	71	0
K935230	EMIT IIC NEGATIVE CONTROL, CONTROL I AND II	Syva Co.	1994-01-03	63	0
K934121	VISTA FOLATE ASSAY	Syva Co.	1993-10-22	58	0
K932716	EMIT(R) THC 50/100 NG ASSAY	Syva Co.	1993-10-01	119	0
K926090	SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT	Syva Co.	1993-09-30	302	0
K931123	DIGOXIN TEST SYSTEM, KXT TX	Syva Co.	1993-08-05	154	0
K931576	VISTA FERRITIN ASSAY	Syva Co.	1993-08-05	128	0
K931535	EMIT(R) D.A.U. BARBITURATE ASSAY	Syva Co.	1993-06-15	78	0
K926422	VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY	Syva Co.	1993-06-02	161	0
K926394	VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY	Syva Co.	1993-05-26	156	0
K931536	EMIT(R) D.A.U. BENZODIAZEPINE ASSAY	Syva Co.	1993-05-11	43	0
K926386	VISTA PROLACTIN ASSAY	Syva Co.	1993-03-29	97	0
K926342	VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY	Syva Co.	1993-02-17	62	0
K926067	EMIT(R) II BENZODIAZEPINE ASSAY	Syva Co.	1993-01-12	42	0
K926068	EMIT(R) II BARBITURATE ASSAY	Syva Co.	1993-01-12	42	0
K923572	VISTA FREE THYROXINE ASSAY	Syva Co.	1992-11-16	122	0
K923873	SYVA EMIT II PROPOXYPHENE ASSAY	Syva Co.	1992-11-02	91	0
K923571	VISTA TRIIODOTHYRONINE ASSAY	Syva Co.	1992-10-15	90	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