The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid-qc Hcg Control Level 1, 2, And 3.
| Device ID | K022232 |
| 510k Number | K022232 |
| Device Name: | CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 |
| Classification | Single (specified) Analyte 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-10 |
| Decision Date | 2002-08-01 |