The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Iron/total Iron Binding Capacity.
| Device ID | K901561 |
| 510k Number | K901561 |
| Device Name: | IRON/TOTAL IRON BINDING CAPACITY |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | TECH-CO, INC. 1856 STAR-BATT DR. Rochester Hills, MI 48309 |
| Contact | Chen, Ph.d. |
| Correspondent | Chen, Ph.d. TECH-CO, INC. 1856 STAR-BATT DR. Rochester Hills, MI 48309 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002003 | K901561 | 000 |
| 10673486001983 | K901561 | 000 |