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510(k) K820084

CLOTTING TIME REAGENT by American Dade — Product Code GJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1982
Date Received
January 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thrombin
Device Class
Class II
Regulation Number
864.7875
Review Panel
HE
Submission Type

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