The following data is part of a premarket notification filed by Prisma Systems with the FDA for Procheq 1 & 2.
| Device ID | K944059 |
| 510k Number | K944059 |
| Device Name: | PROCHEQ 1 & 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440 |
| Contact | Larry J Beasley |
| Correspondent | Larry J Beasley PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-19 |
| Decision Date | 1994-11-15 |