The following data is part of a premarket notification filed by Prisma Systems with the FDA for Ck Qvet.
| Device ID | K950177 |
| 510k Number | K950177 |
| Device Name: | CK QVET |
| Classification | Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes |
| Applicant | PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440 |
| Contact | Patricia L Earl |
| Correspondent | Patricia L Earl PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440 |
| Product Code | CGS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-03-03 |