The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Protein I Calibration Verifiers Levels A=e For Beckman Coulter Immage.
| Device ID | K013332 |
| 510k Number | K013332 |
| Device Name: | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE |
| 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 | 2001-10-09 |
| Decision Date | 2001-11-20 |