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510(k) K072304

FIBRINOGEN CALIBRATOR KIT by Dade Behring, Inc. — Product Code GFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2007
Date Received
August 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen Standard
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

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Other clearances for product code GFX

  • K994341 — FIBRINOGEN CALIBRATOR KIT (March 3, 2000)
  • K812628 — ACA FIBRINOGEN CALIBRATOR (November 24, 1981)