The following data is part of a premarket notification filed by Prisma Systems with the FDA for Cholesterol Qvet.
| Device ID | K943027 |
| 510k Number | K943027 |
| Device Name: | CHOLESTEROL QVET |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440 |
| Contact | Larry Beasley |
| Correspondent | Larry Beasley PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1995-01-27 |