The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Durazyme(r) Cpk.
| Device ID | K883504 |
| 510k Number | K883504 |
| Device Name: | DURAZYME(R) CPK |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-17 |
| Decision Date | 1988-09-13 |