The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid Qc Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin Calibration Verifiers Levels A-e.
| Device ID | K052679 |
| 510k Number | K052679 |
| Device Name: | CLINIQA LIQUID QC BILIRUBIN CONTROLS LEVELS 1, 2 & 3; CLINIQA LINICAL BILIRUBIN CALIBRATION VERIFIERS LEVELS A-E |
| 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 | 2005-09-28 |
| Decision Date | 2005-11-18 |
| Summary: | summary |