The following data is part of a premarket notification filed by Ansys, Inc. with the FDA for On.site Alcohol.
| Device ID | K963197 |
| 510k Number | K963197 |
| Device Name: | ON.SITE ALCOHOL |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | ANSYS, INC. 2 GOODYEAR Irvine, CA 92618 -2054 |
| Contact | Lorna Gamboa |
| Correspondent | Lorna Gamboa ANSYS, INC. 2 GOODYEAR Irvine, CA 92618 -2054 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1996-09-19 |
| Summary: | summary |