The following data is part of a premarket notification filed by Toxi-lab, Inc. with the FDA for On*site Alcohol.
| Device ID | K923337 |
| 510k Number | K923337 |
| Device Name: | ON*SITE ALCOHOL |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | TOXI-LAB, INC. 2 GOODYEAR Irvine, CA 92718 |
| Contact | Stephen K Schulthei |
| Correspondent | Stephen K Schulthei TOXI-LAB, INC. 2 GOODYEAR Irvine, CA 92718 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-18 |
| Decision Date | 1993-01-12 |