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510(k) K851126

ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC by E.I. Dupont DE Nemours & Co., Inc. — Product Code GGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1985
Date Received
March 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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