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510(k) K924370

STACLOT(R) PNP TEST KIT by American Bioproducts Co. — Product Code GGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
August 28, 1992
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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