510(k) K013272
- Device
- ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
- Applicant
- BAYER CORP.
- 510(k) number
- K013272
- Product code
- KLS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-25
- Date received
- 2001-10-01
- Regulation
- 862.3880
- Classification name
- Enzyme Immunoassay, Theophylline
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH T EDDS
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 3006198300
- 3003795116
- 1181121
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 1319808
- 3010939897
- 1181055
- 2517506
- 1036362
- 3004493545
- 3002642396
- 2050010
- 3010825766
- 9610126
- 1319681
- 3000308930
- 3002806944
- 3003561301
Source Documents#
Other 510(k) Records For Product Code KLS #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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