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510(k) K964934

THROMBONOSTIKA F1.2 by Organon Teknika Corp. — Product Code MIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1997
Date Received
December 9, 1996
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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  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
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Other clearances for product code MIF

  • K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KIT (December 10, 2004)
  • 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)