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510(k) K910617

NATIVE PROTHROMBIN ANTIGEN EIA by Organon Teknika Corp. — Product Code DDF

K910617 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "NATIVE PROTHROMBIN ANTIGEN EIA". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code DDF (Prothrombin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5735. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
February 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prothrombin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5735
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 DDF

  • K812985 — AGGLUTEX MORPHINE TEST KIT (December 31, 1981)

FDA data resources