The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Creatine Kinase.
| Device ID | K160570 |
| 510k Number | K160570 |
| Device Name: | Creatine Kinase |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, MD 46250 |
| Contact | Noel B. Mencias |
| Correspondent | Noel B. Mencias Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis, MD 46250 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-29 |
| Decision Date | 2016-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121122 | K160570 | 000 |