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

DLZ — Predicate Candidate Screening

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

56 daysmedian FDA review time

148 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K210858	VITROS Chemistry Products PHBR Slides	Ortho-Clinical Diagnostics, Inc.	2021-08-13	143	0
K123271	ABBOTT PHENOBARBITAL ASSAY	Microgenics Corp.	2013-04-26	189	0
K081231	ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBIT	Abbott Laboratories	2008-09-26	148	0
K071644	ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620	Roche Diagnostics Corp.	2007-09-12	89	0
K011303	RANDOX PHENOBARBITAL	Randox Laboratories, Ltd.	2001-07-02	63	0
K011528	EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229	Syva Co.	2001-06-06	20	3
K000012	IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5	Diagnostic Products Corp.	2000-03-03	60	0
K993031	ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E	Syva Co.	2000-01-27	140	2
K984288	VITROS CHEMISTRY PRODUCTS PHBR SLIDES	Ortho-Clinical Diagnostics, Inc.	1999-01-26	56	3
K946210	PHENOBARBITAL ENZYME IMMUNOASSAY	Diagnostic Reagents, Inc.	1995-02-10	51	0
K943981	IL TEST PHENOBARBITAL CALIBRATORS	Instrumentation Laboratory CO	1995-01-18	225	0
K944932	PHENOBARBITAL FLEX REAGENT CARTRIDGE	Dupont Medical Products	1994-12-28	83	0
K942501	ACE CEDIA PHENOBARBITAL ASSAY	Schiapparelli Biosystems, Inc.	1994-10-06	135	0
K935568	PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS	Baxter Diagnostics, Inc.	1994-03-11	113	0
K913190	EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS	Syva Co.	1991-08-26	39	3
K910355	IL PHENOBARBITAL ASSAY SYSTEM	Instrumentation Laboratory CO	1991-04-03	64	0
K896861	OPUS PHENOBARBITAL TEST SYSTEM	Pb Diagnostic Systems, Inc.	1990-01-11	37	0
K884419	TECHNICON RA-PHENOBARBITAL	Technicon Instruments Corp.	1988-11-22	33	0
K874625	EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY	Syva Co.	1987-12-22	42	0
K864926	EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95	Em Diagnostic Systems, Inc.	1987-01-07	22	0
K854607	ACCULEVEL PHENOBARBITAL TEST	Syva Co.	1986-08-25	280	0
K862308	EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93	Em Diagnostic Systems, Inc.	1986-07-07	20	0
K860365	PHENOBARBITAL TEST SYSTEM	Allied Instrumentation Laboratory	1986-03-17	42	0
K860046	DETERMINATION OF PHENOBARBITAL	Clinical Data, Inc.	1986-01-22	16	0
K852946	SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT	Miles Laboratories, Inc.	1985-09-30	81	0
K852995	ENDAB PHENOBARBITAL	Immunotech Corp.	1985-08-12	28	0
K842264	VENTREZYME PHENOBARBITAL KIT IMMUNO	Ventrex Laboratories, Inc.	1984-08-14	68	0
K833796	CHEM KIT PHENOBARBITAL	Abbott Laboratories	1984-01-30	90	0
K834216	EMIT QST PHENOBARBITAL ASSAY	Syva Co.	1984-01-24	50	0
K832457	A-GENT PHENOBARBITAL	Abbott Laboratories	1983-09-12	48	0
K832097	PHENOBARTIAL ASSAY USE ON COBAS-BIO	Syva Co.	1983-08-11	43	0
K811621	EMIT-ST SERUM PHENOBARBITAL ASSAY	Syva Co.	1981-06-25	17	0
K811367	KALLESTAD ANTISERA TO PHENOBARBITAL	Kallestad Laboratories, Inc.	1981-05-29	15	0
K802039	PHENOBARBITAL REAGENT TEST KIT	Beckman Instruments, Inc.	1980-10-23	59	0
K770919	PHENOBARBITAL ANALYTICAL TEST PACKS	E.I. Dupont DE Nemours & Co., Inc.	1977-06-22	34	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