Panels › Clinical Toxicology › Product code KLS · Class 2
Enzyme Immunoassay, Theophylline
Regulation 862.3880
0510(k)s in 12 months (71 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in KLS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 2004 | K042520 | VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. | KLS |
| Oct 28, 2004 | K042407 | EMIT CAFFEINE ASSAY Dade Behring, Inc. | KLS |
| Apr 16, 2002 | K020740 | ROCHE ONLINE THEOPHYLLINE Roche Diagnostics Corp. | KLS |
| Jan 17, 2002 | K011771 | RANDOX THEOPHYLLINE Randox Laboratories, Ltd., GB | KLS |
| Oct 25, 2001 | K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY Bayer Corp. | KLS |
| May 10, 2001 | K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 Syva Co., Dade Behring, Inc. | KLS |
| Jan 27, 2000 | K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 Syva Co. | KLS |
| Nov 12, 1997 | K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS Schiapparelli Biosystems, Inc. | KLS |
| Oct 10, 1997 | K972495 | ACCUMETER THEOPHYLLINE TEST Chemtrak, Inc. | KLS |
| Jun 27, 1996 | K961462 | CEDIA THEOPHYLLINE ASSAY Boehringer Mannheim Corp. | KLS |
| Nov 13, 1995 | K954569 | IMMULITE THEOPHYLLINE Diagnostic Products Corp. | KLS |
| Aug 11, 1995 | K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | KLS |
| Jan 18, 1995 | K943979 | IL TEST THEOPHYLLINE Instrumentation Laboratory CO | KLS |
| Jun 21, 1994 | K935373 | AXSYM THEOPHYLLINE Abbott Laboratories | KLS |
| Sep 24, 1993 | K932685 | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS Baxter Diagnostics, Inc. | KLS |
| Aug 16, 1993 | K933258 | VIDAS THEOPHYLLINE(THEO) Biomerieux Vitek, Inc. | KLS |
| May 6, 1993 | K926245 | ABBOTT VISION THEOPHYLLINE IIA Abbott Laboratories | KLS |
| Sep 19, 1991 | K913123 | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS Syva Co. | KLS |
| May 8, 1991 | K911060 | IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM Immunomatrix | KLS |
| Apr 3, 1991 | K910697 | IL THEOPHYLLINE ASSAY SYSTEM Instrumentation Laboratory CO | KLS |
| Jul 5, 1990 | K902243 | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES Technicon Instruments Corp. | KLS |
| Jun 12, 1990 | K901510 | ENZYMATIC THEOPHYLLINE REAGENT, #500-82 Diagnostic Chemicals, Ltd. (Usa) | KLS |
| May 30, 1990 | K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE Biotrack, Inc. | KLS |
| Mar 29, 1990 | K900009 | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET Kallestad Diag, A Div. of Erbamont, Inc. | KLS |
| Jan 18, 1990 | K896927 | VISION THEOPHYLLINE II Abbott Laboratories | KLS |
| Mar 31, 1989 | K885253 | ACCULEVEL ONE-STEP THEOPHYLLINE TEST Syva Co. | KLS |
| Feb 7, 1989 | K884358 | CEDIA THEOPHYLLINE ASSAY Microgenics Corp. | KLS |
| Jan 23, 1989 | K890002 | COAT-A-COUNT (TM) THEOPHYLLINE Diagnostic Products Corp. | KLS |
| Dec 29, 1988 | K885044 | BEHRING POLAROID OPUS THEOPHYLLINE Pb Diagnostic Systems, Inc. | KLS |
| Oct 31, 1988 | K884002 | ANALYST THEOPHYLLINE ROTOR The DU Pont Co. | KLS |
| May 27, 1988 | K881257 | EZ-BEAD THEOPHYLLINE ENZYME IMMUNOASSAY KIT Immunotech Corp. | KLS |
| Nov 24, 1987 | K874578 | EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY Syva Co. | KLS |
| Oct 20, 1987 | K873596 | BAKER TDM THEOPHYLLINE ASSAY Baker Instructions Corp. | KLS |
| Apr 14, 1987 | K870736 | DART THEOPHYLLINE REAGENT SYSTEM Coulter Electronics, Inc. | KLS |
| Mar 31, 1987 | K870952 | THEOPHYLLINE FPIA REAGENT SET Sigma Diagnostics, Inc. | KLS |
| Nov 25, 1986 | K864041 | EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 Em Diagnostic Systems, Inc. | KLS |
| Sep 25, 1986 | K862955 | METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM E.I. Dupont DE Nemours & Co., Inc. | KLS |
| Jul 7, 1986 | K862350 | EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 Em Diagnostic Systems, Inc. | KLS |
| Jun 17, 1986 | K860464 | VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM Abbott Laboratories | KLS |
| Jun 13, 1986 | K853872 | EMIT CAFFEINE ASSAY Syva Co. | KLS |
| May 29, 1986 | K861367 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) Eastman Kodak Company | KLS |
| Apr 11, 1986 | K855227 | MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL Bioclinical Systems, Inc. | KLS |
| Dec 19, 1985 | K854183 | IN VITRO TEST DETERMINATION OF THEOPHYLLINE Clinical Data, Inc. | KLS |
| Oct 15, 1985 | K853858 | IL TEST THEOPHYLLINE ASSAY Allied Instrumentation Laboratory | KLS |
| Oct 15, 1985 | K853834 | VISION THEOPHYLLINE Abbott Laboratories | KLS |
| Sep 4, 1985 | K853372 | GEMSTAR IPA THEOPHYLLINE TEST KIT Electro-Nucleonics Laboratories, Inc. | KLS |
| Jul 12, 1985 | K852573 | TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE Technicon Instruments Corp. | KLS |
| Jun 6, 1985 | K851741 | ACCULEVEL THEOPHYLLINE TEST(MODIFICATION) Syva Co. | KLS |
| Mar 29, 1985 | K850856 | ICS THEOPHYLLINE REAGENTS Beckman Instruments, Inc. | KLS |
| Mar 19, 1985 | K844642 | ACCULEVEL THEOPHYLLINE TEST Syva Co. | KLS |
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