The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid Qc Cardiac Marker Control Levels 1, 2 & 3, Tri-level.
| Device ID | K030768 |
| 510k Number | K030768 |
| Device Name: | CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL |
| Classification | Enzyme Controls (assayed And Unassayed) |
| 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 | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-03-21 |