The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Total T4 Fpia Reagent Set/calibrator #t-1039,t-116.
| Device ID | K932980 |
| 510k Number | K932980 |
| Device Name: | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Barry Robins |
| Correspondent | Barry Robins SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-17 |
| Decision Date | 1993-10-18 |