The following data is part of a premarket notification filed by Harleco with the FDA for Iron Set, Item No. 65008.
| Device ID | K771927 |
| 510k Number | K771927 |
| Device Name: | IRON SET, ITEM NO. 65008 |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | HARLECO 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 | 1977-10-14 |
| Decision Date | 1977-11-14 |