The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Cyclosporin A (whole Blood) Control - Levels 1,2,3.
Device ID | K864456 |
510k Number | K864456 |
Device Name: | CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 |
Classification | Drug Specific Control Materials |
Applicant | CALA DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
Contact | James F Godfrey |
Correspondent | James F Godfrey CALA DIAGNOSTICS P.O. BOX 6714 Los Osos, CA 93412 |
Product Code | LAS |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-11-13 |
Decision Date | 1987-05-06 |