The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3.
| Device ID | K083554 |
| 510k Number | K083554 |
| Device Name: | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Contact | Dawn Gast |
| Correspondent | Dawn Gast CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-01 |
| Decision Date | 2009-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238010448 | K083554 | 000 |
| 00817238010431 | K083554 | 000 |
| 00817238010424 | K083554 | 000 |
| 00817238010417 | K083554 | 000 |
| 00817238010400 | K083554 | 000 |
| 00817238010196 | K083554 | 000 |
| 00817238010141 | K083554 | 000 |