The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Iron & Iron Binding Capacity Reagent.
| Device ID | K854305 |
| 510k Number | K854305 |
| Device Name: | DART IRON & IRON BINDING CAPACITY REAGENT |
| Classification | Bathophenanthroline, Colorimetry, Iron (non-heme) |
| Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Contact | Richard-jones |
| Correspondent | Richard-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Product Code | CFM |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-25 |
| Decision Date | 1985-11-12 |