The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid Qc Urine Chemistry Controls, Levels 1 And 2.
| Device ID | K082107 |
| 510k Number | K082107 |
| Device Name: | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero 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 | 2008-07-25 |
| Decision Date | 2008-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238010318 | K082107 | 000 |
| 00857969006419 | K082107 | 000 |