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 |