The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Serum Uibc-ptf-600 Method.
| Device ID | K831202 |
| 510k Number | K831202 |
| Device Name: | SERUM UIBC-PTF-600 METHOD |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-13 |
| Decision Date | 1983-05-25 |