Panels › Clinical Toxicology › Product code DLZ · Class 2
Enzyme Immunoassay, Phenobarbital
Regulation 862.3660
0510(k)s in 12 months (35 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in DLZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2021 | K210858 | VITROS Chemistry Products PHBR Slides Ortho-Clinical Diagnostics, Inc. | DLZ |
| Apr 26, 2013 | K123271 | ABBOTT PHENOBARBITAL ASSAY Microgenics Corp. | DLZ |
| Sep 26, 2008 | K081231 | ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 Abbott Laboratories | DLZ |
| Sep 12, 2007 | K071644 | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 Roche Diagnostics Corp. | DLZ |
| Jul 2, 2001 | K011303 | RANDOX PHENOBARBITAL Randox Laboratories, Ltd., IE | DLZ |
| Jun 6, 2001 | K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 Syva Co. | DLZ |
| Mar 3, 2000 | K000012 | IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 Diagnostic Products Corp. | DLZ |
| Jan 27, 2000 | K993031 | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 Syva Co. | DLZ |
| Jan 26, 1999 | K984288 | VITROS CHEMISTRY PRODUCTS PHBR SLIDES Ortho-Clinical Diagnostics, Inc. | DLZ |
| Feb 10, 1995 | K946210 | PHENOBARBITAL ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | DLZ |
| Jan 18, 1995 | K943981 | IL TEST PHENOBARBITAL CALIBRATORS Instrumentation Laboratory CO | DLZ |
| Dec 28, 1994 | K944932 | PHENOBARBITAL FLEX REAGENT CARTRIDGE Dupont Medical Products | DLZ |
| Oct 6, 1994 | K942501 | ACE CEDIA PHENOBARBITAL ASSAY Schiapparelli Biosystems, Inc. | DLZ |
| Mar 11, 1994 | K935568 | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS Baxter Diagnostics, Inc. | DLZ |
| Aug 26, 1991 | K913190 | EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS Syva Co. | DLZ |
| Apr 3, 1991 | K910355 | IL PHENOBARBITAL ASSAY SYSTEM Instrumentation Laboratory CO | DLZ |
| Jan 11, 1990 | K896861 | OPUS PHENOBARBITAL TEST SYSTEM Pb Diagnostic Systems, Inc. | DLZ |
| Nov 22, 1988 | K884419 | TECHNICON RA-PHENOBARBITAL Technicon Instruments Corp. | DLZ |
| Dec 22, 1987 | K874625 | EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY Syva Co. | DLZ |
| Jan 7, 1987 | K864926 | EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 Em Diagnostic Systems, Inc. | DLZ |
| Aug 25, 1986 | K854607 | ACCULEVEL PHENOBARBITAL TEST Syva Co. | DLZ |
| Jul 7, 1986 | K862308 | EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 Em Diagnostic Systems, Inc. | DLZ |
| Mar 17, 1986 | K860365 | PHENOBARBITAL TEST SYSTEM Allied Instrumentation Laboratory | DLZ |
| Jan 22, 1986 | K860046 | DETERMINATION OF PHENOBARBITAL Clinical Data, Inc. | DLZ |
| Sep 30, 1985 | K852946 | SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT Miles Laboratories, Inc. | DLZ |
| Aug 12, 1985 | K852995 | ENDAB PHENOBARBITAL Immunotech Corp. | DLZ |
| Aug 14, 1984 | K842264 | VENTREZYME PHENOBARBITAL KIT IMMUNO Ventrex Laboratories, Inc. | DLZ |
| Jan 30, 1984 | K833796 | CHEM KIT PHENOBARBITAL Abbott Laboratories | DLZ |
| Jan 24, 1984 | K834216 | EMIT QST PHENOBARBITAL ASSAY Syva Co. | DLZ |
| Sep 12, 1983 | K832457 | A-GENT PHENOBARBITAL Abbott Laboratories | DLZ |
| Aug 11, 1983 | K832097 | PHENOBARTIAL ASSAY USE ON COBAS-BIO Syva Co. | DLZ |
| Jun 25, 1981 | K811621 | EMIT-ST SERUM PHENOBARBITAL ASSAY Syva Co. | DLZ |
| May 29, 1981 | K811367 | KALLESTAD ANTISERA TO PHENOBARBITAL Kallestad Laboratories, Inc. | DLZ |
| Oct 23, 1980 | K802039 | PHENOBARBITAL REAGENT TEST KIT Beckman Instruments, Inc. | DLZ |
| Jun 22, 1977 | K770919 | PHENOBARBITAL ANALYTICAL TEST PACKS E.I. Dupont DE Nemours & Co., Inc. | DLZ |
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