DLZ · Class II · 21 CFR 862.3660

FDA Product Code DLZ: Enzyme Immunoassay, Phenobarbital

Leading manufacturers include Syva Co., Abbott Laboratories and Instrumentation Laboratory CO.

35
Total
35
Cleared
76d
Avg days
1977
Since

FDA 510(k) Cleared Enzyme Immunoassay, Phenobarbital Devices (Product Code DLZ)

35 devices
1–24 of 35
Cleared Aug 13, 2021
VITROS Chemistry Products PHBR Slides
K210858
Ortho-Clinical Diagnostics, Inc.
Toxicology · 143d
Cleared Apr 26, 2013
ABBOTT PHENOBARBITAL ASSAY
K123271
Microgenics Corp.
Chemistry · 189d
Cleared Sep 26, 2008
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
K081231
Abbott Laboratories
Toxicology · 148d
Cleared Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Jul 02, 2001
RANDOX PHENOBARBITAL
K011303
Randox Laboratories, Ltd.
Toxicology · 63d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528
Syva Co.
Chemistry · 20d
Cleared Mar 03, 2000
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012
Diagnostic Products Corp.
Toxicology · 60d
Cleared Jan 27, 2000
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS
K993031
Syva Co.
Toxicology · 140d
Cleared Jan 26, 1999
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
K984288
Ortho-Clinical Diagnostics, Inc.
Toxicology · 56d
Cleared Feb 10, 1995
PHENOBARBITAL ENZYME IMMUNOASSAY
K946210
Diagnostic Reagents, Inc.
Toxicology · 51d
Cleared Jan 18, 1995
IL TEST PHENOBARBITAL CALIBRATORS
K943981
Instrumentation Laboratory CO
Toxicology · 225d
Cleared Dec 28, 1994
PHENOBARBITAL FLEX REAGENT CARTRIDGE
K944932
Dupont Medical Products
Toxicology · 83d
Cleared Oct 06, 1994
ACE CEDIA PHENOBARBITAL ASSAY
K942501
Schiapparelli Biosystems, Inc.
Chemistry · 135d
Cleared Mar 11, 1994
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568
Baxter Diagnostics, Inc.
Toxicology · 113d
Cleared Aug 26, 1991
EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K913190
Syva Co.
Toxicology · 39d
Cleared Apr 03, 1991
IL PHENOBARBITAL ASSAY SYSTEM
K910355
Instrumentation Laboratory CO
Toxicology · 64d
Cleared Jan 11, 1990
OPUS PHENOBARBITAL TEST SYSTEM
K896861
Pb Diagnostic Systems, Inc.
Toxicology · 37d
Cleared Nov 22, 1988
TECHNICON RA-PHENOBARBITAL
K884419
Technicon Instruments Corp.
Toxicology · 33d
Cleared Dec 22, 1987
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY
K874625
Syva Co.
Toxicology · 42d
Cleared Jan 07, 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Aug 25, 1986
ACCULEVEL PHENOBARBITAL TEST
K854607
Syva Co.
Toxicology · 280d
Cleared Jul 07, 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
K862308
Em Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Jan 22, 1986
DETERMINATION OF PHENOBARBITAL
K860046
Clinical Data, Inc.
Toxicology · 16d
Cleared Sep 30, 1985
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946
Miles Laboratories, Inc.
Toxicology · 81d

About Product Code DLZ - Regulatory Context