The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Immunodiagnostic Products Ck-mb Reagent Pack.
| Device ID | K212648 |
| 510k Number | K212648 |
| Device Name: | VITROS Immunodiagnostic Products CK-MB Reagent Pack |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | Ortho Clinical Diagnostics Felindre Meadows Pencoed, GB Cf35 5pz |
| Contact | Declan Hynes |
| Correspondent | Declan Hynes Ortho Clinical Diagnostics Felindre Meadows Pencoed, GB Cf35 5pz |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10758750034314 | K212648 | 000 |