Enzyme Immunoassay, Theophylline

FDA product code KLS · 71 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3880
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-03-27 – 2004-11-30

KLS 2004-11-30

VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III

Applicant Ortho-Clinical Diagnostics, Inc.

K number K042520

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KLS 2004-10-28

EMIT CAFFEINE ASSAY

Applicant Dade Behring, Inc.

K number K042407

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KLS 2002-04-16

ROCHE ONLINE THEOPHYLLINE

Applicant Roche Diagnostics Corp.

K number K020740

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KLS 2002-01-17

RANDOX THEOPHYLLINE

Applicant Randox Laboratories, Ltd.

K number K011771

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KLS 2001-10-25

ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY

Applicant Bayer Corp.

K number K013272

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KLS 2001-05-10

MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229

Applicant Syva Co., Dade Behring, Inc.

K number K011166

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KLS 2000-01-27

ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89

Applicant Syva Co.

K number K993029

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KLS 1997-11-12

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS

Applicant Schiapparelli Biosystems, Inc.

K number K973583

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KLS 1997-10-10

ACCUMETER THEOPHYLLINE TEST

Applicant Chemtrak, Inc.

K number K972495

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KLS 1996-06-27

CEDIA THEOPHYLLINE ASSAY

Applicant Boehringer Mannheim Corp.

K number K961462

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KLS 1995-11-13

IMMULITE THEOPHYLLINE

Applicant Diagnostic Products Corp.

K number K954569

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KLS 1995-08-11

THEOPHYLLINE ENZYME IMMUNOASSAY

Applicant Diagnostic Reagents, Inc.

K number K952596

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KLS 1995-01-18

IL TEST THEOPHYLLINE

Applicant Instrumentation Laboratory CO

K number K943979

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KLS 1994-06-21

AXSYM THEOPHYLLINE

Applicant Abbott Laboratories

K number K935373

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KLS 1993-09-24

PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS

Applicant Baxter Diagnostics, Inc.

K number K932685

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KLS 1993-08-16

VIDAS THEOPHYLLINE(THEO)

Applicant Biomerieux Vitek, Inc.

K number K933258

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KLS 1993-05-06

ABBOTT VISION THEOPHYLLINE IIA

Applicant Abbott Laboratories

K number K926245

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KLS 1991-09-19

EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS

Applicant Syva Co.

K number K913123

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KLS 1991-05-08

IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM

Applicant Immunomatrix

K number K911060

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KLS 1991-04-03

IL THEOPHYLLINE ASSAY SYSTEM

Applicant Instrumentation Laboratory CO

K number K910697

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KLS 1990-07-05

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

Applicant Technicon Instruments Corp.

K number K902243

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KLS 1990-06-12

ENZYMATIC THEOPHYLLINE REAGENT, #500-82

Applicant Diagnostic Chemicals, Ltd. (Usa)

K number K901510

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KLS 1990-05-30

BIOTRACK THEOPHYLLINE TEST CARTRIDGE

Applicant Biotrack, Inc.

K number K900373

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KLS 1990-03-29

NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET

Applicant Kallestad Diag, A Div. of Erbamont, Inc.

K number K900009

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KLS 1990-01-18

VISION THEOPHYLLINE II

Applicant Abbott Laboratories

K number K896927

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KLS 1989-03-31

ACCULEVEL ONE-STEP THEOPHYLLINE TEST

Applicant Syva Co.

K number K885253

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KLS 1989-02-07

CEDIA THEOPHYLLINE ASSAY

Applicant Microgenics Corp.

K number K884358

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KLS 1989-01-23

COAT-A-COUNT (TM) THEOPHYLLINE

Applicant Diagnostic Products Corp.

K number K890002

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KLS 1988-12-29

BEHRING POLAROID OPUS THEOPHYLLINE

Applicant Pb Diagnostic Systems, Inc.

K number K885044

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KLS 1988-10-31

ANALYST THEOPHYLLINE ROTOR

Applicant The DU Pont Co.

K number K884002

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KLS 1988-05-27

EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT

Applicant Immunotech Corp.

K number K881257

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KLS 1987-11-24

EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY

Applicant Syva Co.

K number K874578

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KLS 1987-10-20

BAKER TDM THEOPHYLLINE ASSAY

Applicant Baker Instructions Corp.

K number K873596

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KLS 1987-04-14

DART THEOPHYLLINE REAGENT SYSTEM

Applicant Coulter Electronics, Inc.

K number K870736

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KLS 1987-03-31

THEOPHYLLINE FPIA REAGENT SET

Applicant Sigma Diagnostics, Inc.

K number K870952

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KLS 1986-11-25

EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95

Applicant Em Diagnostic Systems, Inc.

K number K864041

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KLS 1986-09-25

METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM

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

K number K862955

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KLS 1986-07-07

EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93

Applicant Em Diagnostic Systems, Inc.

K number K862350

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KLS 1986-06-17

VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM

Applicant Abbott Laboratories

K number K860464

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KLS 1986-06-13

EMIT CAFFEINE ASSAY

Applicant Syva Co.

K number K853872

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KLS 1986-05-29

KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)

Applicant Eastman Kodak Company

K number K861367

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KLS 1986-04-11

MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL

Applicant Bioclinical Systems, Inc.

K number K855227

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KLS 1985-12-19

IN VITRO TEST DETERMINATION OF THEOPHYLLINE

Applicant Clinical Data, Inc.

K number K854183

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KLS 1985-10-15

IL TEST THEOPHYLLINE ASSAY

Applicant Allied Instrumentation Laboratory

K number K853858

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KLS 1985-10-15

VISION THEOPHYLLINE

Applicant Abbott Laboratories

K number K853834

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KLS 1985-09-04

GEMSTAR IPA THEOPHYLLINE TEST KIT

Applicant Electro-Nucleonics Laboratories, Inc.

K number K853372

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KLS 1985-07-12

TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE

Applicant Technicon Instruments Corp.

K number K852573

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KLS 1985-06-06

ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)

Applicant Syva Co.

K number K851741

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KLS 1985-03-29

ICS THEOPHYLLINE REAGENTS

Applicant Beckman Instruments, Inc.

K number K850856

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KLS 1985-03-19

ACCULEVEL THEOPHYLLINE TEST

Applicant Syva Co.

K number K844642

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KLS 1984-12-11

THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K844170

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KLS 1984-05-22

DUPONT THEOPHYLLINE ASSAY KIT

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

K number K841656

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KLS 1984-03-19

SERALYZER THEOPHYLLINE REAGENT STRIPS

Applicant Miles Laboratories, Inc.

K number K832825

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KLS 1984-01-30

VENTREZYME THEOPHYLLINE IMMUNOASSAY

Applicant Vxr, Inc.

K number K833989

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KLS 1984-01-24

THEOFAST TEST KIT FOR QUANTITATIVE THEO

Applicant Allergenetics

K number K834244

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KLS 1983-12-30

STRATUS THEOPHYLLINE ASSAY

Applicant American Dade

K number K832965

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KLS 1983-12-27

CHEM KIT THEOPHYLLINE DIAG. KIT

Applicant Abbott Laboratories

K number K833683

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KLS 1983-09-12

THEOPHYLLINE TEST PACK ACA

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

K number K831934

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KLS 1983-08-01

EMIT AAD THEOPHYLLINE ASSAY

Applicant Syva Co.

K number K832034

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KLS 1983-05-27

EMIT QST THEOPHYLLINE ASSAY

Applicant Syva Co.

K number K831272

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KLS 1982-06-10

DETECTION OF THEOPHYLLINE

Applicant Electro-Nucleonics Laboratories, Inc.

K number K821544

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KLS 1982-05-13

KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME

Applicant Jay Rau, Technical Suppprt

K number K821154

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KLS 1981-07-27

A-GENT THEOPHYLLINE

Applicant Abbott Laboratories

K number K812003

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KLS 1981-03-13

BECKMAN THEOPHYLLINE REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K810578

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KLS 1981-03-06

COPPER SULFATE SOLUTION SP. GR.1.053

Applicant Accra Laboratories, Inc.

K number K803094

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KLS 1980-10-23

ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY

Applicant Immunotech Corp.

K number K802066

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KLS 1980-08-27

FIAX TEST KIT FOR THEOPHYLLINE QUANT.

Applicant Intl. Diagnostic Technology

K number K801642

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KLS 1980-07-08

APPLICATION OF EMIT THEOPHYLLINE ASSAY

Applicant Syva Co.

K number K801476

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KLS 1980-04-10

AMES TDA THEOPHYL-LINE TEST

Applicant Miles Laboratories, Inc.

K number K800646

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KLS 1979-03-02

EMIT THEOPHYLLINE ASSAY

Applicant Syva Co.

K number K790256

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KLS 1978-03-27

IN VITRO THEOPHYLLINE RIA TEST

Applicant Clinical Assays, Inc.

K number K772017

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