The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Protein 1 Calibration Verifiers Levels A - E For Olympus Au Analyzers.
Device ID | K040927 |
510k Number | K040927 |
Device Name: | LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS |
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 | 2004-04-09 |
Decision Date | 2004-05-17 |