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510(k) K904341

APTT REAGENT by Sigma Chemical Co. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1990
Date Received
September 20, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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