The following data is part of a premarket notification filed by Volu Sol Medical Industries with the FDA for Agglutinotest-toxoplasmosis.
Device ID | K791456 |
510k Number | K791456 |
Device Name: | AGGLUTINOTEST-TOXOPLASMOSIS |
Classification | Antigens, Cf, Toxoplasma Gondii |
Applicant | VOLU SOL MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GMN |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-06 |
Decision Date | 1979-09-24 |