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510(k) K923593

HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS by International Technidyne Corp. — Product Code KQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1992
Date Received
July 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Fibrinogen Determination
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

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  • K970189 — FIF TM (May 21, 1997)
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  • K934326 — MULTIFIBREN U (April 19, 1994)
  • K931721 — IL TEST FIBRINOGEN-C (August 13, 1993)
  • K922416 — FIBRINOGEN RID TEST KIT (March 9, 1993)
  • K925988 — MULTIFIBREN (March 1, 1993)