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
Stable submission activity - 0 submissions in the last 2 years

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 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
Cleared Aug 12, 1985
ENDAB PHENOBARBITAL
K852995
Immunotech Corp.
Toxicology · 28d
Cleared Aug 14, 1984
VENTREZYME PHENOBARBITAL KIT IMMUNO
K842264
Ventrex Laboratories, Inc.
Toxicology · 68d

About Product Code DLZ - Regulatory Context

510(k) Submission Activity

35 total 510(k) submissions under product code DLZ since 1977, with 35 receiving FDA clearance (average review time: 76 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.