The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Sia Thyroid Stimulating Hormone Elisa Kit.
| Device ID | K930050 |
| 510k Number | K930050 |
| Device Name: | SIA THYROID STIMULATING HORMONE ELISA KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Daniel E Lawson |
| Correspondent | Daniel E Lawson SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-05 |
| Decision Date | 1993-08-19 |