The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for Linical Protein 4 Calibration Verifiers Levels-a-e For Beckman Coulter Immage.
Device ID | K022885 |
510k Number | K022885 |
Device Name: | LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE |
Classification | Multi-analyte Controls, All Kinds (assayed) |
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 | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-30 |
Decision Date | 2002-10-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817238010691 | K022885 | 000 |