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510(k) K910617

NATIVE PROTHROMBIN ANTIGEN EIA by Organon Teknika Corp. — Product Code DDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
February 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prothrombin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5735
Review Panel
HE
Submission Type

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  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code DDF

  • K812985 — AGGLUTEX MORPHINE TEST KIT (December 31, 1981)