VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
FDA 510(k) clearance K042520 · decided 2004-11-30
Clearance details
- K-number
- K042520
- Device name
- VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-16
- Decision date
- 2004-11-30
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- KLS
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EMIT CAFFEINE ASSAY (K042407) | Dade Behring, Inc. | 2004-10-28 |
| ROCHE ONLINE THEOPHYLLINE (K020740) | Roche Diagnostics Corp. | 2002-04-16 |
| RANDOX THEOPHYLLINE (K011771) | Randox Laboratories, Ltd. | 2002-01-17 |
| ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY (K013272) | Bayer Corp. | 2001-10-25 |
| MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 (K011166) | Syva Co., Dade Behring, Inc. | 2001-05-10 |
| ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89 (K993029) | Syva Co. | 2000-01-27 |
| ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS (K973583) | Schiapparelli Biosystems, Inc. | 1997-11-12 |
| ACCUMETER THEOPHYLLINE TEST (K972495) | Chemtrak, Inc. | 1997-10-10 |
| CEDIA THEOPHYLLINE ASSAY (K961462) | Boehringer Mannheim Corp. | 1996-06-27 |
| IMMULITE THEOPHYLLINE (K954569) | Diagnostic Products Corp. | 1995-11-13 |
| THEOPHYLLINE ENZYME IMMUNOASSAY (K952596) | Diagnostic Reagents, Inc. | 1995-08-11 |
| IL TEST THEOPHYLLINE (K943979) | Instrumentation Laboratory CO | 1995-01-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Anti-HBc IgM (P030026/S037) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036) | Ortho-Clinical Diagnostics, Inc. | 2020-10-22 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033) | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| VITROS Anti-HBs (P000014/S035) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc IgM (P030026/S036) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS HBeAg (P090028/S017) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |