GOK · Class II · 21 CFR 866.3510

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

Leading manufacturers include Flow Laboratories, Inc., Organon, Inc. 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
Cleared Mar 19, 1980
ANTIBODY TO RUBELLA VIRUS
K792635
Electro-Nucleonics Laboratories, Inc.
Microbiology · 91d
Cleared Feb 15, 1979
RUBANON
K790122
Organon, Inc.
Microbiology · 23d
Cleared Jan 20, 1978
RUBENOSTICON
K780063
Organon, Inc.
Microbiology · 8d
Cleared Oct 28, 1977
HUMAN O BUFFER
K771956
Flow Laboratories, Inc.
Microbiology · 11d
Cleared Oct 28, 1977
RUBELLA HEMAGGLUTINATION REAGENT KIT
K771957
Flow Laboratories, Inc.
Microbiology · 11d

About Product Code GOK - Regulatory Context