DAN · Class II · 21 CFR 866.5350

FDA Product Code DAN: Fibrinopeptide A, Antigen, Antiserum, Control

Leading manufacturers include Mallinckrodt Critical Care and American Bioproducts Co..

3
Total
3
Cleared
69d
Avg days
1982
Since

FDA 510(k) Cleared Fibrinopeptide A, Antigen, Antiserum, Control Devices (Product Code DAN)

3 devices
1–3 of 3
Cleared Feb 04, 1986
ASSERACHROM FPA KIT
K854384
American Bioproducts Co.
Hematology · 97d
Cleared Jul 22, 1982
RIA-QUANT FPA TEST KIT
K821151
Mallinckrodt Critical Care
Immunology · 87d

About Product Code DAN - Regulatory Context