The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Cliniqa Liquid Qc Tdm Controls Levels 1,2 & 3/cliniqa Linical Tdm Calibration Verifiers Levels A-e For Olympus Au System.
| Device ID | K041898 |
| 510k Number | K041898 |
| Device Name: | CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CLINIQA CORPORATION 1432 SOUTH MISSION ROAD Fallbrook, CA 92028 |
| Contact | Carol Ruggiero |
| Correspondent | Carol Ruggiero CLINIQA CORPORATION 1432 SOUTH MISSION ROAD 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 | 2004-07-14 |
| Decision Date | 2004-08-16 |