GOL · Class II · 21 CFR 866.3510

FDA Product Code GOL: Antigen, Ha (including Ha Control), Rubella

Leading manufacturers include Abbott Laboratories, Cordis Corp. and Behring Diagnostics, Inc..

21
Total
21
Cleared
77d
Avg days
1976
Since

FDA 510(k) Cleared Antigen, Ha (including Ha Control), Rubella Devices (Product Code GOL)

21 devices
1–21 of 21
Cleared Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
K834032
Abbott Laboratories
Hematology · 147d
Cleared Dec 18, 1980
EIA RUBELLA-G
K802339
Beckman Instruments, Inc.
Microbiology · 83d
Cleared Jun 20, 1980
MACRO-VUE RUBELLA CARD TEST
K800797
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 72d
Cleared Aug 16, 1979
RUBAZYME
K790976
Abbott Laboratories
Microbiology · 85d
Cleared Apr 12, 1979
CORDIA T
K790212
Cordis Corp.
Immunology · 72d
Cleared Jan 17, 1979
CORDIA R
K780885
Cordis Corp.
Microbiology · 236d
Cleared Oct 18, 1977
RUBA-NOST TEST KITS
K771796
Behring Diagnostics, Inc.
Microbiology · 25d
Cleared Nov 16, 1976
TEST FOR DETECTION OF ANTIRUBELLA ANTIB
K760889
Abbott Laboratories
Immunology · 21d

About Product Code GOL - Regulatory Context