The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 And Aat Performance Verifiers I, Ii And Iii.
| Device ID | K052819 |
| 510k Number | K052819 |
| Device Name: | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III |
| Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Darlene J Phillips |
| Correspondent | Darlene J Phillips Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | DEM |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2005-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750002573 | K052819 | 000 |
| 10758750002566 | K052819 | 000 |
| 10758750002559 | K052819 | 000 |