The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Apoa1 And Apob Reagents, Calibrator Kits 21 And 22 And Apoa1 And Apob Performance Verifiers.
| Device ID | K042521 |
| 510k Number | K042521 |
| Device Name: | VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS |
| Classification | Calibrator, Secondary |
| Applicant | Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Contact | Marlene A Hanna |
| Correspondent | Marlene A Hanna Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101 |
| Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | MSJ |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-16 |
| Decision Date | 2004-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750006878 | K042521 | 000 |
| 10758750006861 | K042521 | 000 |
| 10758750001385 | K042521 | 000 |
| 10758750001378 | K042521 | 000 |