The following data is part of a premarket notification filed by Alpha Gamma Laboratory with the FDA for Gamma Stick 125-1 Tobramycin Ria Kit.
Device ID | K810011 |
510k Number | K810011 |
Device Name: | GAMMA STICK 125-1 TOBRAMYCIN RIA KIT |
Classification | Radioimmunoassay, Tobramycin |
Applicant | ALPHA GAMMA LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLB |
CFR Regulation Number | 862.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-05 |
Decision Date | 1981-01-28 |