The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Omni-fal I & Ii.
| Device ID | K833009 |
| 510k Number | K833009 |
| Device Name: | OMNI-FAL I & II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1984-01-13 |