The following data is part of a premarket notification filed by Seragen Diagnostics, Inc. with the FDA for Direct Iron Reagent Set.
| Device ID | K834396 |
| 510k Number | K834396 |
| Device Name: | DIRECT IRON REAGENT SET |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Applicant | SERAGEN DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-02-21 |