GOE · Class I · 21 CFR 866.3405

FDA Product Code GOE: Antisera, Fluorescent, Poliovirus 1-3

Leading manufacturers include Light Diagnostics and Chemicon Intl., Inc..

7
Total
7
Cleared
608d
Avg days
1995
Since

FDA 510(k) Cleared Antisera, Fluorescent, Poliovirus 1-3 Devices (Product Code GOE)

7 devices
1–7 of 7
Cleared Sep 12, 1995
POLIOVIRUS 3 MONOCLONAL ANTIBODY
K940017
Light Diagnostics
Microbiology · 616d
Cleared Sep 12, 1995
POLIOVIRUS BLEND MONOCLONAL ANTIBODIES
K940026
Light Diagnostics
Microbiology · 617d
Cleared Sep 12, 1995
ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
K940027
Chemicon Intl., Inc.
Microbiology · 617d
Cleared Sep 12, 1995
POLIOVIRUS 2 MONOCLONAL ANTIBODY
K940034
Light Diagnostics
Microbiology · 616d
Cleared Sep 12, 1995
ENTEROVIRUS 71 MONOCLONAL ANTIBODY
K940473
Chemicon Intl., Inc.
Microbiology · 587d
Cleared Sep 08, 1995
POLIOVIRUS 1 MONOCLONAL ANTIBODY
K940018
Light Diagnostics
Microbiology · 612d
Cleared Sep 08, 1995
ENTEROVIRUS 70 MONCLONAL ANTIBODY
K940363
Light Diagnostics
Microbiology · 590d

About Product Code GOE - Regulatory Context