The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Troponin I Es Assay, Including Reagent Pack, Calibrators And Range Verifiers, Models 680 2301, 2302 And 2303.
| Device ID | K062838 |
| 510k Number | K062838 |
| Device Name: | VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Charlotte Baker |
| Correspondent | Charlotte Baker ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | MMI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-21 |
| Decision Date | 2006-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750002528 | K062838 | 000 |