The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Chemistry Calibration Verifiers Levels A - E For Beckman Coulter Synchron Systems.
Device ID | K031921 |
510k Number | K031921 |
Device Name: | LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | CLINIQA CORPORATION 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
Contact | Carol Ruggiero |
Correspondent | Carol Ruggiero CLINIQA CORPORATION 1432-B SOUTH MISSION RD. Fallbrook, CA 92028 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-23 |
Decision Date | 2003-08-25 |