The following data is part of a premarket notification filed by Ortho-clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Tsh Reagent Pack And Calibrators, Vitros 3600 Immunodiagnostic System.
| Device ID | K083173 |
| 510k Number | K083173 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE MC881 Rochester, NY 14626 -5101 |
| Contact | Leah Van De Water |
| Correspondent | Leah Van De Water ORTHO-CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE MC881 Rochester, NY 14626 -5101 |
| Product Code | JLW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-27 |
| Decision Date | 2008-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750007103 | K083173 | 000 |
| 10758750002979 | K083173 | 000 |