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DDF – Prothrombin, Antigen, Antiserum, Control
Prothrombin, Antigen, Antiserum, Control
FDA product code
DDF
· Class I (low risk) · 21 CFR 866.5735 ·
Immunology
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Hoffmann-La Roche, Inc.
1
Organon Teknika Corp.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K910617
Native Prothrombin Antigen Eia
DDF · Traditional
Organon Teknika Corp.
05/15/1991
SE
K812985
Agglutex Morphine Test Kit
DDF · Traditional
Hoffmann-La Roche, Inc.
12/31/1981
SE