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510(k) K042687

ENZYGNOST F+2 (MONOCLONAL) TEST KIT by Dade Behring, Inc. — Product Code MIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2004
Date Received
September 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prothrombin Fragment 1.2
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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Other clearances for product code MIF

  • K964934 — THROMBONOSTIKA F1.2 (March 18, 1997)
  • K962176 — TPP (October 18, 1996)
  • K922934 — ENZYGNOST F 1+2 (November 16, 1992)
  • K920895 — DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA (June 4, 1992)
  • K911434 — THROMBONOSTIKA F1.2 (October 31, 1991)