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510(k) K913861

HEMOCHRON(R) KACT by International Technidyne Corp. — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1991
Date Received
August 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

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  • K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (September 30, 1998)

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