The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus Total Ck.
| Device ID | K933675 |
| 510k Number | K933675 |
| Device Name: | OPUS TOTAL CK |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy M Johansen |
| Correspondent | Nancy M Johansen PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-28 |
| Decision Date | 1993-09-08 |