GPW · Class I · 21 CFR 866.3120

FDA Product Code GPW: Antigen, Cf, Psittacosis (chlamydia Group)

Leading manufacturers include Electro-Nucleonics Laboratories, Inc., Institute Virion , Ltd. and Hillcrest Biologicals.

4
Total
4
Cleared
139d
Avg days
1981
Since

FDA 510(k) Cleared Antigen, Cf, Psittacosis (chlamydia Group) Devices (Product Code GPW)

4 devices
1–4 of 4
Cleared Oct 15, 1987
YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN
K872700
Sita, Inc.
Microbiology · 100d
Cleared Aug 08, 1985
CHLAMYDIA
K843654
Institute Virion , Ltd.
Microbiology · 325d
Cleared Mar 05, 1985
CHLAMYDIA GROUP CF ANTIGEN
K844868
Hillcrest Biologicals
Microbiology · 81d
Cleared Jul 23, 1981
ANTIBODY TO CHLAMYDIA TRACHOMATIS
K811570
Electro-Nucleonics Laboratories, Inc.
Microbiology · 49d

About Product Code GPW - Regulatory Context