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510(k) K941210

PTT-LT TEST KIT by American Bioproducts Co. — Product Code GGW

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 21, 1995
Date Received
March 14, 1994
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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