GOK · Class II · 21 CFR 866.3510

FDA Product Code GOK: Antisera, Hai (including Hai Control), Rubella

Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic and Abbott Laboratories.

11
Total
11
Cleared
48d
Avg days
1977
Since

FDA 510(k) Cleared Antisera, Hai (including Hai Control), Rubella Devices (Product Code GOK)

11 devices
1–11 of 11
Cleared Sep 29, 1983
RUBASCAN LATEX CARD TEST
K832228
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 80d
Cleared May 05, 1981
RUBAZYME - M
K810835
Abbott Laboratories
Immunology · 41d

About Product Code GOK - Regulatory Context