The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Immuno 1 Tm System Additional Analytes.
| Device ID | K912616 |
| 510k Number | K912616 |
| Device Name: | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Thomas C Brewster |
| Correspondent | Thomas C Brewster TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-13 |
| Decision Date | 1991-09-25 |