The following data is part of a premarket notification filed by Si Sero-immuno Diagnostics, Inc. with the FDA for Hem Ave-toxo Titration Hemagglutination Test Kit.
Device ID | K851977 |
510k Number | K851977 |
Device Name: | HEM AVE-TOXO TITRATION 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 |