The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid Qc Urinalysis Controls, Levels 1 And 2.
| Device ID | K081908 |
| 510k Number | K081908 |
| Device Name: | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| 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 | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-03 |
| Decision Date | 2009-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817238010516 | K081908 | 000 |
| 00817238010509 | K081908 | 000 |
| 00817238010493 | K081908 | 000 |
| 00817238010486 | K081908 | 000 |
| 04987562433469 | K081908 | 000 |