GSN · Class II · 21 CFR 866.3085

FDA Product Code GSN: Antiserum, Positive And Negative Febrile Antigen Control Serum

Leading manufacturers include Immuno-Mycologics, Inc., Investigacion Farmaceutica S.A. DE C.V. and Sa Scientific, Inc..

3
Total
3
Cleared
118d
Avg days
1979
Since

FDA 510(k) Cleared Antiserum, Positive And Negative Febrile Antigen Control Serum Devices (Product Code GSN)

3 devices
1–3 of 3
Cleared Jul 18, 1995
SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM
K952145
Sa Scientific, Inc.
Microbiology · 71d
Cleared Aug 15, 1989
IFA* POSITIVE AND NEGATIVE ANTIGENS CONTROL
K885113
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 246d
Cleared Aug 16, 1979
NEGATIVE CONTROL SERUM FOR CF RO ID
K791385
Immuno-Mycologics, Inc.
Microbiology · 36d

About Product Code GSN - Regulatory Context