The following data is part of a premarket notification filed by Prisma Systems with the FDA for Potassium Qvet.
Device ID | K943026 |
510k Number | K943026 |
Device Name: | POTASSIUM QVET |
Classification | Tetraphenyl Borate, Colorimetry, Potassium |
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 | CEJ |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-27 |
Decision Date | 1994-12-09 |