The following data is part of a premarket notification filed by Syn-kit, Inc. with the FDA for Toxotest-mt Eiken Kit.
Device ID | K802452 |
510k Number | K802452 |
Device Name: | TOXOTEST-MT EIKEN KIT |
Classification | Antigens, Iha, Toxoplasma Gondii |
Applicant | SYN-KIT, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | GMM |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-08 |
Decision Date | 1980-12-18 |