Atlas FDA

DLZ

35 FDA 510(k) clearances · Product code

56 daysmedian time to decision
148 days90th percentile
35clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Phenobarbital
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3660
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 1 · 2006: 8 · 2007: 3 · 2011: 58 · 2012: 222 · 2013: 101
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
VITROS Chemistry Products PHBR Slides (K210858)Ortho-Clinical Diagnostics, Inc.2021-08-13
ABBOTT PHENOBARBITAL ASSAY (K123271)Microgenics Corp.2013-04-26
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 (K081231)Abbott Laboratories2008-09-26
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (K071644)Roche Diagnostics Corp.2007-09-12
RANDOX PHENOBARBITAL (K011303)Randox Laboratories, Ltd.2001-07-02
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (K011528)Syva Co.2001-06-06
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 (K000012)Diagnostic Products Corp.2000-03-03
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (K993031)Syva Co.2000-01-27
VITROS CHEMISTRY PRODUCTS PHBR SLIDES (K984288)Ortho-Clinical Diagnostics, Inc.1999-01-26
PHENOBARBITAL ENZYME IMMUNOASSAY (K946210)Diagnostic Reagents, Inc.1995-02-10
IL TEST PHENOBARBITAL CALIBRATORS (K943981)Instrumentation Laboratory CO1995-01-18
PHENOBARBITAL FLEX REAGENT CARTRIDGE (K944932)Dupont Medical Products1994-12-28
ACE CEDIA PHENOBARBITAL ASSAY (K942501)Schiapparelli Biosystems, Inc.1994-10-06
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS (K935568)Baxter Diagnostics, Inc.1994-03-11
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS (K913190)Syva Co.1991-08-26
IL PHENOBARBITAL ASSAY SYSTEM (K910355)Instrumentation Laboratory CO1991-04-03
OPUS PHENOBARBITAL TEST SYSTEM (K896861)Pb Diagnostic Systems, Inc.1990-01-11
TECHNICON RA-PHENOBARBITAL (K884419)Technicon Instruments Corp.1988-11-22
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY (K874625)Syva Co.1987-12-22
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 (K864926)Em Diagnostic Systems, Inc.1987-01-07
ACCULEVEL PHENOBARBITAL TEST (K854607)Syva Co.1986-08-25
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 (K862308)Em Diagnostic Systems, Inc.1986-07-07
PHENOBARBITAL TEST SYSTEM (K860365)Allied Instrumentation Laboratory1986-03-17
DETERMINATION OF PHENOBARBITAL (K860046)Clinical Data, Inc.1986-01-22
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT (K852946)Miles Laboratories, Inc.1985-09-30
ENDAB PHENOBARBITAL (K852995)Immunotech Corp.1985-08-12
VENTREZYME PHENOBARBITAL KIT IMMUNO (K842264)Ventrex Laboratories, Inc.1984-08-14
CHEM KIT PHENOBARBITAL (K833796)Abbott Laboratories1984-01-30
EMIT QST PHENOBARBITAL ASSAY (K834216)Syva Co.1984-01-24
A-GENT PHENOBARBITAL (K832457)Abbott Laboratories1983-09-12
PHENOBARTIAL ASSAY USE ON COBAS-BIO (K832097)Syva Co.1983-08-11
EMIT-ST SERUM PHENOBARBITAL ASSAY (K811621)Syva Co.1981-06-25
KALLESTAD ANTISERA TO PHENOBARBITAL (K811367)Kallestad Laboratories, Inc.1981-05-29
PHENOBARBITAL REAGENT TEST KIT (K802039)Beckman Instruments, Inc.1980-10-23
PHENOBARBITAL ANALYTICAL TEST PACKS (K770919)E.I. Dupont DE Nemours & Co., Inc.1977-06-22

Track DLZ automatically

Every clearance here is in the API, with alerts when new ones post.