The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Analyte Iron/technicon Chem 1 System.
| Device ID | K860799 |
| 510k Number | K860799 |
| Device Name: | ANALYTE IRON/TECHNICON CHEM 1 SYSTEM |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-04-03 |