The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Enzyme Calibration Verifiers Levels A-e For Beckman Coulter Synchron Systems.
| Device ID | K040535 |
| 510k Number | K040535 |
| Device Name: | LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook, CA 92028 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero CLINIQA CORPORATION 1432 SOUTH MISSION RD. Fallbrook, CA 92028 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-03-29 |