Product code KLS— Clinical Toxicology
CEDIA THEOPHYLLINE ASSAY
- Classification name
- Enzyme Immunoassay, Theophylline
- Device class
- Class 2
- Regulation
- 21 CFR 862.3880
- Advisory panel
- Clinical Toxicology
- Total cleared
- 71
- First cleared
- Most recent
Market context for product code KLS
FDA has cleared devices under product code KLS between 1978 and 2004, filed by 45 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2004
- 2002
- 2001
- 2000
- 1997
- 1996
- 1995
- 1994
- 1993
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
Top applicants under product code KLS
Recent clearances under product code KLS
- K042520 — VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
- K042407 — EMIT CAFFEINE ASSAY
- K020740 — ROCHE ONLINE THEOPHYLLINE
- K011771 — RANDOX THEOPHYLLINE
- K013272 — ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
- K011166 — MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
- K993029 — ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
- K973583 — ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS
- K972495 — ACCUMETER THEOPHYLLINE TEST
- K961462 — CEDIA THEOPHYLLINE ASSAY
- K954569 — IMMULITE THEOPHYLLINE
- K952596 — THEOPHYLLINE ENZYME IMMUNOASSAY
- K943979 — IL TEST THEOPHYLLINE
- K935373 — AXSYM THEOPHYLLINE
- K932685 — PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS
- K933258 — VIDAS THEOPHYLLINE(THEO)
- K926245 — ABBOTT VISION THEOPHYLLINE IIA
- K913123 — EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS
- K911060 — IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM
- K910697 — IL THEOPHYLLINE ASSAY SYSTEM
- K902243 — TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
- K901510 — ENZYMATIC THEOPHYLLINE REAGENT, #500-82
- K900373 — BIOTRACK THEOPHYLLINE TEST CARTRIDGE
- K900009 — NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
- K896927 — VISION THEOPHYLLINE II
- K885253 — ACCULEVEL ONE-STEP THEOPHYLLINE TEST
- K884358 — CEDIA THEOPHYLLINE ASSAY
- K890002 — COAT-A-COUNT (TM) THEOPHYLLINE
- K885044 — BEHRING POLAROID OPUS THEOPHYLLINE
- K884002 — ANALYST THEOPHYLLINE ROTOR
- K881257 — EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT
- K874578 — EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY
- K873596 — BAKER TDM THEOPHYLLINE ASSAY
- K870736 — DART THEOPHYLLINE REAGENT SYSTEM
- K870952 — THEOPHYLLINE FPIA REAGENT SET
- K864041 — EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
- K862955 — METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
- K862350 — EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
- K860464 — VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM
- K853872 — EMIT CAFFEINE ASSAY
- K861367 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
- K855227 — MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
- K854183 — IN VITRO TEST DETERMINATION OF THEOPHYLLINE
- K853834 — VISION THEOPHYLLINE
- K853858 — IL TEST THEOPHYLLINE ASSAY
- K853372 — GEMSTAR IPA THEOPHYLLINE TEST KIT
- K852573 — TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE
- K851741 — ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
- K850856 — ICS THEOPHYLLINE REAGENTS
- K844642 — ACCULEVEL THEOPHYLLINE TEST
- K844170 — THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM
- K841656 — DUPONT THEOPHYLLINE ASSAY KIT
- K832825 — SERALYZER THEOPHYLLINE REAGENT STRIPS
- K833989 — VENTREZYME THEOPHYLLINE IMMUNOASSAY
- K834244 — THEOFAST TEST KIT FOR QUANTITATIVE THEO
- K832965 — STRATUS THEOPHYLLINE ASSAY
- K833683 — CHEM KIT THEOPHYLLINE DIAG. KIT
- K831934 — THEOPHYLLINE TEST PACK ACA
- K832034 — EMIT AAD THEOPHYLLINE ASSAY
- K831272 — EMIT QST THEOPHYLLINE ASSAY
- K821544 — DETECTION OF THEOPHYLLINE
- K821154 — KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME
- K812003 — A-GENT THEOPHYLLINE
- K810578 — BECKMAN THEOPHYLLINE REAGENT TEST KIT
- K803094 — COPPER SULFATE SOLUTION SP. GR.1.053
- K802066 — ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
- K801642 — FIAX TEST KIT FOR THEOPHYLLINE QUANT.
- K801476 — APPLICATION OF EMIT THEOPHYLLINE ASSAY
- K800646 — AMES TDA THEOPHYL-LINE TEST
- K790256 — EMIT THEOPHYLLINE ASSAY
- K772017 — IN VITRO THEOPHYLLINE RIA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.