The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Ra(r) Analyte (tbg) (30 C And 37 C).
| Device ID | K874658 |
| 510k Number | K874658 |
| Device Name: | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| 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 | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-12 |
| Decision Date | 1987-12-18 |