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Device Classification
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DDF — Prothrombin, Antigen, Antiserum, Control
Class I
FDA Device Classification
Classification Details
Product Code
DDF
Device Class
Class I
Regulation Number
866.5735
Submission Type
Review Panel
HE
Medical Specialty
Immunology
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K910617
organon teknika
NATIVE PROTHROMBIN ANTIGEN EIA
May 15, 1991
K812985
hoffmann-la roche
AGGLUTEX MORPHINE TEST KIT
December 31, 1981