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 |