The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Chem 1 Uibc (iron Binding Capacity Test).
| Device ID | K883104 |
| 510k Number | K883104 |
| Device Name: | CHEM 1 UIBC (IRON BINDING CAPACITY TEST) |
| Classification | Ferrozine (colorimetric) Iron Binding Capacity |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard Dwarica |
| Correspondent | Leonard Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JMO |
| CFR Regulation Number | 862.1415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-25 |
| Decision Date | 1988-10-25 |