The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Ckmb Control For Mass Measurement-levels 1,2,3.
| Device ID | K926015 |
| 510k Number | K926015 |
| Device Name: | CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 |
| Classification | Single (specified) Analyte 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-30 |
| Decision Date | 1992-12-28 |