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510(k) K941007

CATALOG NO. J-ACT+ & QC-ACT+ by International Technidyne Corp. — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1994
Date Received
March 1, 1994
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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