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510(k) K951072

PROTIME MICROCOAGULATION SYSTEM by International Technidyne Corp. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1995
Date Received
March 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (April 13, 1999)
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