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510(k) K983475

HEMOCHRON RESPONSE by International Technidyne Corp. — Product Code KQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1999
Date Received
October 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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