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510(k) K884179

TURBOX FIBRINOGEN by Unipath , Ltd. — Product Code KQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1988
Date Received
September 30, 1988
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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  • 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)