The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Ethanol Calibrator.
| Device ID | K872181 |
| 510k Number | K872181 |
| Device Name: | ETHANOL CALIBRATOR |
| Classification | Calibrators, Drug Specific |
| 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 | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-08 |
| Decision Date | 1987-07-21 |