The following data is part of a premarket notification filed by Si Sero-immuno Diagnostics, Inc. with the FDA for Hem Ave-toxo Screening Hemagglutination Test Kit.
| Device ID | K851976 |
| 510k Number | K851976 |
| Device Name: | HEM AVE-TOXO SCREENING HEMAGGLUTINATION TEST KIT |
| Classification | Antigens, Iha, Toxoplasma Gondii |
| Applicant | SI SERO-IMMUNO DIAGNOSTICS, INC. P.O. BOX 1230 Tucker, GA 30085 |
| Contact | Irving G Kagan |
| Correspondent | Irving G Kagan SI SERO-IMMUNO DIAGNOSTICS, INC. P.O. BOX 1230 Tucker, GA 30085 |
| Product Code | GMM |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-10-16 |