The following data is part of a premarket notification filed by Alpha Gamma Laboratory with the FDA for Gamma Stick Gentamicin Ria Kit.
| Device ID | K800537 |
| 510k Number | K800537 |
| Device Name: | GAMMA STICK GENTAMICIN RIA KIT |
| Classification | Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
| Applicant | ALPHA GAMMA LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DJB |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-10 |
| Decision Date | 1980-04-24 |