The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Iron Binding Capicity Model 0370.
| Device ID | K781865 |
| 510k Number | K781865 |
| Device Name: | IRON BINDING CAPICITY MODEL 0370 |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-06 |
| Decision Date | 1978-12-04 |