The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Dry Qc Chemistry Control, Levels 1 And 2, Assayed, Cliniqa Dry Qc Chemistry Control, Level 1 And 2 Unassayed.
| Device ID | K060322 |
| 510k Number | K060322 |
| Device Name: | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED |
| Classification | Calibrator, Secondary |
| Applicant | CLINIQA CORPORATION 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero CLINIQA CORPORATION 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-03-21 |