The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Febrile Antigens & Control Serums.
| Device ID | K760097 |
| 510k Number | K760097 |
| Device Name: | FEBRILE ANTIGENS & CONTROL SERUMS |
| Classification | Antigens, Febrile (weil-felix), All Groups |
| Applicant | GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GSZ |
| CFR Regulation Number | 866.3410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-14 |
| Decision Date | 1976-08-03 |