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 |