The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid Qc Complete Cardiac Marker Control, Levels 1,2, And 3; Cardiac Marker Control-low, And Linical Cardiac.
| Device ID | K080973 |
| 510k Number | K080973 |
| Device Name: | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD. San Marcos, CA 92069 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero CLINIQA CORPORATION 774 N. TWIN OAKS VALLEY RD. San Marcos, CA 92069 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2008-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238011629 | K080973 | 000 |
| 00817238011636 | K080973 | 000 |
| 00817238011643 | K080973 | 000 |
| 00817238010059 | K080973 | 000 |
| 00817238010066 | K080973 | 000 |
| 00817238010073 | K080973 | 000 |
| 00817238010264 | K080973 | 000 |
| 00817238011513 | K080973 | 000 |
| 00817238011605 | K080973 | 000 |
| 00817238011612 | K080973 | 000 |
| 00817238010028 | K080973 | 000 |