The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Serum Iron-ptf-600.
| Device ID | K831201 |
| 510k Number | K831201 |
| Device Name: | SERUM IRON-PTF-600 |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-13 |
| Decision Date | 1983-05-25 |