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510(k) K812628

ACA FIBRINOGEN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code GFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
September 15, 1981
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

  • K072304 — FIBRINOGEN CALIBRATOR KIT (September 19, 2007)
  • K994341 — FIBRINOGEN CALIBRATOR KIT (March 3, 2000)