Enzyme Immunoassay, Phenobarbital

FDA product code DLZ · 35 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3660
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-22 – 2021-08-13

DLZ 2021-08-13

VITROS Chemistry Products PHBR Slides

Applicant Ortho-Clinical Diagnostics, Inc.

K number K210858

View details →

DLZ 2013-04-26

ABBOTT PHENOBARBITAL ASSAY

Applicant Microgenics Corp.

K number K123271

View details →

DLZ 2008-09-26

ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33

Applicant Abbott Laboratories

K number K081231

View details →

DLZ 2007-09-12

ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620

Applicant Roche Diagnostics Corp.

K number K071644

View details →

DLZ 2001-07-02

RANDOX PHENOBARBITAL

Applicant Randox Laboratories, Ltd.

K number K011303

View details →

DLZ 2001-06-06

EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

Applicant Syva Co.

K number K011528

View details →

DLZ 2000-03-03

IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5

Applicant Diagnostic Products Corp.

K number K000012

View details →

DLZ 2000-01-27

ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54

Applicant Syva Co.

K number K993031

View details →

DLZ 1999-01-26

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

Applicant Ortho-Clinical Diagnostics, Inc.

K number K984288

View details →

DLZ 1995-02-10

PHENOBARBITAL ENZYME IMMUNOASSAY

Applicant Diagnostic Reagents, Inc.

K number K946210

View details →

DLZ 1995-01-18

IL TEST PHENOBARBITAL CALIBRATORS

Applicant Instrumentation Laboratory CO

K number K943981

View details →

DLZ 1994-12-28

PHENOBARBITAL FLEX REAGENT CARTRIDGE

Applicant Dupont Medical Products

K number K944932

View details →

DLZ 1994-10-06

ACE CEDIA PHENOBARBITAL ASSAY

Applicant Schiapparelli Biosystems, Inc.

K number K942501

View details →

DLZ 1994-03-11

PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS

Applicant Baxter Diagnostics, Inc.

K number K935568

View details →

DLZ 1991-08-26

EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS

Applicant Syva Co.

K number K913190

View details →

DLZ 1991-04-03

IL PHENOBARBITAL ASSAY SYSTEM

Applicant Instrumentation Laboratory CO

K number K910355

View details →

DLZ 1990-01-11

OPUS PHENOBARBITAL TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K896861

View details →

DLZ 1988-11-22

TECHNICON RA-PHENOBARBITAL

Applicant Technicon Instruments Corp.

K number K884419

View details →

DLZ 1987-12-22

EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY

Applicant Syva Co.

K number K874625

View details →

DLZ 1987-01-07

EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95

Applicant Em Diagnostic Systems, Inc.

K number K864926

View details →

DLZ 1986-08-25

ACCULEVEL PHENOBARBITAL TEST

Applicant Syva Co.

K number K854607

View details →

DLZ 1986-07-07

EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93

Applicant Em Diagnostic Systems, Inc.

K number K862308

View details →

DLZ 1986-03-17

PHENOBARBITAL TEST SYSTEM

Applicant Allied Instrumentation Laboratory

K number K860365

View details →

DLZ 1986-01-22

DETERMINATION OF PHENOBARBITAL

Applicant Clinical Data, Inc.

K number K860046

View details →

DLZ 1985-09-30

SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT

Applicant Miles Laboratories, Inc.

K number K852946

View details →

DLZ 1985-08-12

ENDAB PHENOBARBITAL

Applicant Immunotech Corp.

K number K852995

View details →

DLZ 1984-08-14

VENTREZYME PHENOBARBITAL KIT IMMUNO

Applicant Ventrex Laboratories, Inc.

K number K842264

View details →

DLZ 1984-01-30

CHEM KIT PHENOBARBITAL

Applicant Abbott Laboratories

K number K833796

View details →

DLZ 1984-01-24

EMIT QST PHENOBARBITAL ASSAY

Applicant Syva Co.

K number K834216

View details →

DLZ 1983-09-12

A-GENT PHENOBARBITAL

Applicant Abbott Laboratories

K number K832457

View details →

DLZ 1983-08-11

PHENOBARTIAL ASSAY USE ON COBAS-BIO

Applicant Syva Co.

K number K832097

View details →

DLZ 1981-06-25

EMIT-ST SERUM PHENOBARBITAL ASSAY

Applicant Syva Co.

K number K811621

View details →

DLZ 1981-05-29

KALLESTAD ANTISERA TO PHENOBARBITAL

Applicant Kallestad Laboratories, Inc.

K number K811367

View details →

DLZ 1980-10-23

PHENOBARBITAL REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K802039

View details →

DLZ 1977-06-22

PHENOBARBITAL ANALYTICAL TEST PACKS

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K770919

View details →