LLA · Class II · 21 CFR 866.3780

FDA Product Code LLA: Direct Agglutination Test, Toxoplasma Gondii

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic.

4
Total
4
Cleared
217d
Avg days
1983
Since

FDA 510(k) Cleared Direct Agglutination Test, Toxoplasma Gondii Devices (Product Code LLA)

4 devices
1–4 of 4
Cleared May 20, 1985
TOXOSCAN CARD TEST KIT
K850768
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 84d
Cleared Sep 26, 1983
TOXO-SCREEN DA TEST
K831930
Bd Becton Dickinson Vacutainer Systems Preanalytic
Immunology · 103d

About Product Code LLA - Regulatory Context