Product code KLS
- Device name
- Enzyme Immunoassay, Theophylline
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3880
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042520 | VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2004-11-30 |
| K042407 | EMIT CAFFEINE ASSAY | Dade Behring, Inc. | 2004-10-28 |
| K020740 | ROCHE ONLINE THEOPHYLLINE | Roche Diagnostics Corp. | 2002-04-16 |
| K011771 | RANDOX THEOPHYLLINE | Randox Laboratories, Ltd. | 2002-01-17 |
| K013272 | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | Bayer Corp. | 2001-10-25 |
| K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 | Syva Co., Dade Behring, Inc. | 2001-05-10 |
| K993029 | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 | Syva Co. | 2000-01-27 |
| K973583 | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| K972495 | ACCUMETER THEOPHYLLINE TEST | Chemtrak, Inc. | 1997-10-10 |
| K961462 | CEDIA THEOPHYLLINE ASSAY | Boehringer Mannheim Corp. | 1996-06-27 |
| K954569 | IMMULITE THEOPHYLLINE | Diagnostic Products Corp. | 1995-11-13 |
| K952596 | THEOPHYLLINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1995-08-11 |
| K943979 | IL TEST THEOPHYLLINE | Instrumentation Laboratory CO | 1995-01-18 |
| K935373 | AXSYM THEOPHYLLINE | Abbott Laboratories | 1994-06-21 |
| K932685 | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS | Baxter Diagnostics, Inc. | 1993-09-24 |
| K933258 | VIDAS THEOPHYLLINE(THEO) | Biomerieux Vitek, Inc. | 1993-08-16 |
| K926245 | ABBOTT VISION THEOPHYLLINE IIA | Abbott Laboratories | 1993-05-06 |
| K913123 | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS | Syva Co. | 1991-09-19 |
| K911060 | IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM | Immunomatrix | 1991-05-08 |
| K910697 | IL THEOPHYLLINE ASSAY SYSTEM | Instrumentation Laboratory CO | 1991-04-03 |
| K902243 | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES | Technicon Instruments Corp. | 1990-07-05 |
| K901510 | ENZYMATIC THEOPHYLLINE REAGENT, #500-82 | Diagnostic Chemicals, Ltd. (Usa) | 1990-06-12 |
| K900373 | BIOTRACK THEOPHYLLINE TEST CARTRIDGE | Biotrack, Inc. | 1990-05-30 |
| K900009 | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-29 |
| K896927 | VISION THEOPHYLLINE II | Abbott Laboratories | 1990-01-18 |
| K885253 | ACCULEVEL ONE-STEP THEOPHYLLINE TEST | Syva Co. | 1989-03-31 |
| K884358 | CEDIA THEOPHYLLINE ASSAY | Microgenics Corp. | 1989-02-07 |
| K890002 | COAT-A-COUNT (TM) THEOPHYLLINE | Diagnostic Products Corp. | 1989-01-23 |
| K885044 | BEHRING POLAROID OPUS THEOPHYLLINE | Pb Diagnostic Systems, Inc. | 1988-12-29 |
| K884002 | ANALYST THEOPHYLLINE ROTOR | The DU Pont Co. | 1988-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336147931 | ONLINE TDM Theophylline | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740154127 | Alinity | ABBOTT LABORATORIES | 2019-01-02 |
| 00630414596006 | Atellica CH Theo | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 00842768015458 | Dimension Vista® Flex® reagent cartridge THEO | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414966571 | IMMULITE®/IMMULITE® 1000 Systems THE Theophylline | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414966311 | IMMULITE® 2000 Systems THE Theophylline | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414561905 | ADVIA® Chemistry THEO_2 Theophylline_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414460963 | ADVIA Centaur® THEO 2 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414460956 | ADVIA Centaur® THEO 2 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414460918 | ADVIA Centaur® Systems Calibrator 27 | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023286 | Emit® 2000 Theophylline Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005664 | Dimension® Flex® reagent cartridge THEO | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001413 | Syva® Emit® Caffeine Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001031 | Syva® Emit® 2000 Theophylline Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001024 | Syva® Emit® 2000 Theophylline Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273206432 | THEO | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 04015630997169 | ONLINE TDM Theophylline | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630999934 | Theophylline | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883001275 | CEDIA Theophylline II Assay | Microgenics Corporation | 2016-09-12 |
| 10758750008759 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 10758750004706 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590232078 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750006779 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 00380740102715 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |