The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Immuno/febrile Antigens.
| Device ID | K883685 |
| 510k Number | K883685 |
| Device Name: | IMMUNO/FEBRILE ANTIGENS |
| Classification | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. |
| Applicant | IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Kenneth Kupits |
| Correspondent | Kenneth Kupits IMMUNOSTICS CO., INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | GNC |
| CFR Regulation Number | 866.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-09-28 |