The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Serum Iron & Serum Iron Binding Capacity.
| Device ID | K842156 |
| 510k Number | K842156 |
| Device Name: | SERUM IRON & SERUM IRON BINDING CAPACITY |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-08-07 |