KLS — Enzyme Immunoassay, Theophylline Class II
FDA product code KLS covers "Enzyme Immunoassay, Theophylline", a Class II medical device regulated under 21 CFR 862.3880. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLS
- Device Class
- Class II
- Regulation Number
- 862.3880
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K042520 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II | November 30, 2004 |
| K042407 | dade behring | EMIT CAFFEINE ASSAY | October 28, 2004 |
| K020740 | roche diagnostics | ROCHE ONLINE THEOPHYLLINE | April 16, 2002 |
| K011771 | randox laboratories | RANDOX THEOPHYLLINE | January 17, 2002 |
| K013272 | bayer | ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY | October 25, 2001 |
| K011166 | syva co., dade behring | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 | May 10, 2001 |
| K993029 | syva | ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 | January 27, 2000 |
| K973583 | schiapparelli biosystems | ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS | November 12, 1997 |
| K972495 | chemtrak | ACCUMETER THEOPHYLLINE TEST | October 10, 1997 |
| K961462 | boehringer mannheim | CEDIA THEOPHYLLINE ASSAY | June 27, 1996 |
| K954569 | diagnostic products | IMMULITE THEOPHYLLINE | November 13, 1995 |
| K952596 | diagnostic reagents | THEOPHYLLINE ENZYME IMMUNOASSAY | August 11, 1995 |
| K943979 | instrumentation laboratory | IL TEST THEOPHYLLINE | January 18, 1995 |
| K935373 | abbott laboratories | AXSYM THEOPHYLLINE | June 21, 1994 |
| K932685 | baxter diagnostics | PARAMAX(R) THEOPHYLLINE REAGENT AND CALIBRATORS | September 24, 1993 |
| K933258 | biomerieux vitek | VIDAS THEOPHYLLINE(THEO) | August 16, 1993 |
| K926245 | abbott laboratories | ABBOTT VISION THEOPHYLLINE IIA | May 6, 1993 |
| K913123 | syva | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS | September 19, 1991 |
| K911060 | immunomatrix | IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM | May 8, 1991 |
| K910697 | instrumentation laboratory | IL THEOPHYLLINE ASSAY SYSTEM | April 3, 1991 |