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510(k) K964934

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

K964934 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "THROMBONOSTIKA F1.2". The FDA issued a decision of Substantially Equivalent on March 18, 1997. The device falls under product code MIF (Prothrombin Fragment 1.2), a Class II device regulated under 21 CFR 864.7320. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K000492 — MDA D-DIMER (June 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (March 2, 2000)
  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

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)

FDA data resources