The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Tsh Reagent Pack And Calibrators, Vitros 5600 Integrated System.
| Device ID | K081543 |
| 510k Number | K081543 |
| Device Name: | VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DRIVE MC881 Rochester, NY 14626 -5101 |
| Contact | Leah Van De Water |
| Correspondent | Leah Van De Water Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DRIVE MC881 Rochester, NY 14626 -5101 |
| Product Code | JLW |
| Subsequent Product Code | DIP |
| 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 | 2008-06-02 |
| Decision Date | 2008-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750033515 | K081543 | 000 |
| 10758750009862 | K081543 | 000 |
| 10758750007110 | K081543 | 000 |
| 10758750002740 | K081543 | 000 |