The following data is part of a premarket notification filed by Prisma Systems with the FDA for Bilirubin (direct) Qvet.
| Device ID | K942949 |
| 510k Number | K942949 |
| Device Name: | BILIRUBIN (DIRECT) QVET |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | PRISMA SYSTEMS 1721 BLACK RIVER BLVD. SUITE 200 Rome, NY 13440 |
| Contact | Larry J Beasley |
| Correspondent | Larry J Beasley PRISMA SYSTEMS 1721 BLACK RIVER BLVD. SUITE 200 Rome, NY 13440 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-23 |
| Decision Date | 1994-11-22 |