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510(k) K960749

HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT by International Technidyne Corp. — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1996
Date Received
February 23, 1996
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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  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (April 13, 1999)
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