The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Kinetic 610 Ethanol.
| Device ID | K872180 |
| 510k Number | K872180 |
| Device Name: | KINETIC 610 ETHANOL |
| Classification | Nad-nadh, Specific Reagent For Alcohol Enzyme Method |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Luann Ochs |
| Correspondent | Luann Ochs AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | DML |
| CFR Regulation Number | 862.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-07-07 |