The following data is part of a premarket notification filed by Alpha Gamma Laboratory with the FDA for Gamma Stik 125i T3 Uptake Kit.
| Device ID | K780492 |
| 510k Number | K780492 |
| Device Name: | GAMMA STIK 125I T3 UPTAKE KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | ALPHA GAMMA LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-27 |
| Decision Date | 1978-04-28 |