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510(k) K954997

CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT by Centocor, Inc. — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1996
Date Received
November 1, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

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