The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Ck 1-3, Ld 1-5 Isoenzyme Control Human Levels 1/2/.
| Device ID | K850907 |
| 510k Number | K850907 |
| Device Name: | CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ |
| Classification | Enzyme Controls (assayed And Unassayed) |
| 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 | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-05 |
| Decision Date | 1985-06-25 |