GOL · Class II · 21 CFR 866.3510

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

Leading manufacturers include Abbott Laboratories, Flow Laboratories, Inc. and Cordis Corp..

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 Jun 07, 1984
RUBELLA ANTIBODY FLUOROIMMUNOASSAY
K841174
Intl. Diagnostic Technology
Microbiology · 80d
Cleared Apr 17, 1984
RUBAQUICK DIAGNOSTIC KIT
K834032
Abbott Laboratories
Hematology · 147d
Cleared Mar 11, 1981
RUBELLA ANTIBODIES TEST REAGENTS
K810309
Calbiochem-Behring Corp.
Immunology · 34d
Cleared Dec 18, 1980
RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
K802102
Calbiochem-Behring Corp.
Immunology · 106d
Cleared Dec 18, 1980
EIA RUBELLA-G
K802339
Beckman Instruments, Inc.
Microbiology · 83d
Cleared Sep 16, 1980
ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
K801098
Flow Laboratories, Inc.
Microbiology · 130d
Cleared Jun 20, 1980
MACRO-VUE RUBELLA CARD TEST
K800797
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 72d
Cleared Jan 23, 1980
FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
K792249
Intl. Diagnostic Technology
Microbiology · 77d
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 May 20, 1977
MEASLES-FA LABELLED (8-441 RF)
K770805
Flow Laboratories, Inc.
Immunology · 17d
Cleared May 20, 1977
MEASLES-FA LABELED PRESERUM (8-441 RNF)
K770809
Flow Laboratories, Inc.
Immunology · 17d
Cleared Nov 16, 1976
TEST FOR DETECTION OF ANTIRUBELLA ANTIB
K760889
Abbott Laboratories
Immunology · 21d

About Product Code GOL - Regulatory Context