DDF · Class I · 21 CFR 866.5735

FDA Product Code DDF: Prothrombin, Antigen, Antiserum, Control

Leading manufacturers include Hoffmann-La Roche, Inc. and Organon Teknika Corp..

2
Total
2
Cleared
79d
Avg days
1981
Since

FDA 510(k) Cleared Prothrombin, Antigen, Antiserum, Control Devices (Product Code DDF)

2 devices
1–2 of 2
Cleared May 15, 1991
NATIVE PROTHROMBIN ANTIGEN EIA
K910617
Organon Teknika Corp.
Immunology · 92d
Cleared Dec 31, 1981
AGGLUTEX MORPHINE TEST KIT
K812985
Hoffmann-La Roche, Inc.
Toxicology · 66d

About Product Code DDF - Regulatory Context