GON · Class II · 21 CFR 866.3510

FDA Product Code GON: Antigen, Cf (including Cf Control), Rubella

Leading manufacturers include Orion Diagnostica, Inc. and Syva Co..

5
Total
5
Cleared
77d
Avg days
1978
Since

FDA 510(k) Cleared Antigen, Cf (including Cf Control), Rubella Devices (Product Code GON)

5 devices
1–5 of 5
Cleared Feb 04, 1988
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
K880157
Syva Co.
Microbiology · 22d
Cleared Dec 31, 1980
RUBELLA VIRUS ANTIGENS & CONTROLS
K802937
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
HERPES SIMPLEX TYPE I
K802939
Orion Diagnostica, Inc.
Microbiology · 42d

About Product Code GON - Regulatory Context