The following data is part of a premarket notification filed by Cala Diagnostics with the FDA for Serum Alcohol Control Levels 1, 2 & 3.
| Device ID | K912827 |
| 510k Number | K912827 |
| Device Name: | SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 |
| Classification | Alcohol 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 | DKC |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-26 |
| Decision Date | 1991-08-12 |