The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Roche Diagnostics Ck-mb.
| Device ID | K003158 |
| 510k Number | K003158 |
| Device Name: | ROCHE DIAGNOSTICS CK-MB |
| Classification | U.v. Method, Cpk Isoenzymes |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Kay A Talor |
| Correspondent | Kay A Talor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JHW |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-10 |
| Decision Date | 2000-12-18 |