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510(k) K800656

A-GENT QUANTICHROM THROMBIGEN-E by Abbott Laboratories — Product Code GGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
March 25, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Prothrombin Consumption
Device Class
Class II
Regulation Number
864.7720
Review Panel
HE
Submission Type

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