The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Total T-3 Fpia Reagent Set, Total T-3 Fpia Calibrators.
| Device ID | K952557 |
| 510k Number | K952557 |
| Device Name: | TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Hoyle D Hill |
| Correspondent | Hoyle D Hill SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-02 |
| Decision Date | 1996-01-24 |