Atlas FDA

KLS

71 FDA 510(k) clearances · Product code

48 daysmedian time to decision
140 days90th percentile
71clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Theophylline
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3880
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III (K042520)Ortho-Clinical Diagnostics, Inc.2004-11-30
EMIT CAFFEINE ASSAY (K042407)Dade Behring, Inc.2004-10-28
ROCHE ONLINE THEOPHYLLINE (K020740)Roche Diagnostics Corp.2002-04-16
RANDOX THEOPHYLLINE (K011771)Randox Laboratories, Ltd.2002-01-17
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (K013272)Bayer Corp.2001-10-25
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (K011166)Syva Co., Dade Behring, Inc.2001-05-10
ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (K993029)Syva Co.2000-01-27
ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (K973583)Schiapparelli Biosystems, Inc.1997-11-12
ACCUMETER THEOPHYLLINE TEST (K972495)Chemtrak, Inc.1997-10-10
CEDIA THEOPHYLLINE ASSAY (K961462)Boehringer Mannheim Corp.1996-06-27
IMMULITE THEOPHYLLINE (K954569)Diagnostic Products Corp.1995-11-13
THEOPHYLLINE ENZYME IMMUNOASSAY (K952596)Diagnostic Reagents, Inc.1995-08-11
IL TEST THEOPHYLLINE (K943979)Instrumentation Laboratory CO1995-01-18
AXSYM THEOPHYLLINE (K935373)Abbott Laboratories1994-06-21
PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS (K932685)Baxter Diagnostics, Inc.1993-09-24
VIDAS THEOPHYLLINE(THEO) (K933258)Biomerieux Vitek, Inc.1993-08-16
ABBOTT VISION THEOPHYLLINE IIA (K926245)Abbott Laboratories1993-05-06
EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS (K913123)Syva Co.1991-09-19
IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM (K911060)Immunomatrix1991-05-08
IL THEOPHYLLINE ASSAY SYSTEM (K910697)Instrumentation Laboratory CO1991-04-03
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES (K902243)Technicon Instruments Corp.1990-07-05
ENZYMATIC THEOPHYLLINE REAGENT, #500-82 (K901510)Diagnostic Chemicals, Ltd. (Usa)1990-06-12
BIOTRACK THEOPHYLLINE TEST CARTRIDGE (K900373)Biotrack, Inc.1990-05-30
NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET (K900009)Kallestad Diag, A Div. of Erbamont, Inc.1990-03-29
VISION THEOPHYLLINE II (K896927)Abbott Laboratories1990-01-18
ACCULEVEL ONE-STEP THEOPHYLLINE TEST (K885253)Syva Co.1989-03-31
CEDIA THEOPHYLLINE ASSAY (K884358)Microgenics Corp.1989-02-07
COAT-A-COUNT (TM) THEOPHYLLINE (K890002)Diagnostic Products Corp.1989-01-23
BEHRING POLAROID OPUS THEOPHYLLINE (K885044)Pb Diagnostic Systems, Inc.1988-12-29
ANALYST THEOPHYLLINE ROTOR (K884002)The DU Pont Co.1988-10-31
EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT (K881257)Immunotech Corp.1988-05-27
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY (K874578)Syva Co.1987-11-24
BAKER TDM THEOPHYLLINE ASSAY (K873596)Baker Instructions Corp.1987-10-20
DART THEOPHYLLINE REAGENT SYSTEM (K870736)Coulter Electronics, Inc.1987-04-14
THEOPHYLLINE FPIA REAGENT SET (K870952)Sigma Diagnostics, Inc.1987-03-31
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 (K864041)Em Diagnostic Systems, Inc.1986-11-25
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM (K862955)E.I. Dupont DE Nemours & Co., Inc.1986-09-25
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 (K862350)Em Diagnostic Systems, Inc.1986-07-07
VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM (K860464)Abbott Laboratories1986-06-17
EMIT CAFFEINE ASSAY (K853872)Syva Co.1986-06-13
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) (K861367)Eastman Kodak Company1986-05-29
MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL (K855227)Bioclinical Systems, Inc.1986-04-11
IN VITRO TEST DETERMINATION OF THEOPHYLLINE (K854183)Clinical Data, Inc.1985-12-19
VISION THEOPHYLLINE (K853834)Abbott Laboratories1985-10-15
IL TEST THEOPHYLLINE ASSAY (K853858)Allied Instrumentation Laboratory1985-10-15
GEMSTAR IPA THEOPHYLLINE TEST KIT (K853372)Electro-Nucleonics Laboratories, Inc.1985-09-04
TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE (K852573)Technicon Instruments Corp.1985-07-12
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION) (K851741)Syva Co.1985-06-06
ICS THEOPHYLLINE REAGENTS (K850856)Beckman Instruments, Inc.1985-03-29
ACCULEVEL THEOPHYLLINE TEST (K844642)Syva Co.1985-03-19
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM (K844170)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-11
DUPONT THEOPHYLLINE ASSAY KIT (K841656)E.I. Dupont DE Nemours & Co., Inc.1984-05-22
SERALYZER THEOPHYLLINE REAGENT STRIPS (K832825)Miles Laboratories, Inc.1984-03-19
VENTREZYME THEOPHYLLINE IMMUNOASSAY (K833989)Vxr, Inc.1984-01-30
THEOFAST TEST KIT FOR QUANTITATIVE THEO (K834244)Allergenetics1984-01-24
STRATUS THEOPHYLLINE ASSAY (K832965)American Dade1983-12-30
CHEM KIT THEOPHYLLINE DIAG. KIT (K833683)Abbott Laboratories1983-12-27
THEOPHYLLINE TEST PACK ACA (K831934)E.I. Dupont DE Nemours & Co., Inc.1983-09-12
EMIT AAD THEOPHYLLINE ASSAY (K832034)Syva Co.1983-08-01
EMIT QST THEOPHYLLINE ASSAY (K831272)Syva Co.1983-05-27
DETECTION OF THEOPHYLLINE (K821544)Electro-Nucleonics Laboratories, Inc.1982-06-10
KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME (K821154)Jay Rau, Technical Suppprt1982-05-13
A-GENT THEOPHYLLINE (K812003)Abbott Laboratories1981-07-27
BECKMAN THEOPHYLLINE REAGENT TEST KIT (K810578)Beckman Instruments, Inc.1981-03-13
COPPER SULFATE SOLUTION SP. GR.1.053 (K803094)Accra Laboratories, Inc.1981-03-06
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY (K802066)Immunotech Corp.1980-10-23
FIAX TEST KIT FOR THEOPHYLLINE QUANT. (K801642)Intl. Diagnostic Technology1980-08-27
APPLICATION OF EMIT THEOPHYLLINE ASSAY (K801476)Syva Co.1980-07-08
AMES TDA THEOPHYL-LINE TEST (K800646)Miles Laboratories, Inc.1980-04-10
EMIT THEOPHYLLINE ASSAY (K790256)Syva Co.1979-03-02
IN VITRO THEOPHYLLINE RIA TEST (K772017)Clinical Assays, Inc.1978-03-27

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