Home / 510(k) Clearances / K854084

510(k) K854084

PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT by Organon Teknika Corp. — Product Code FKL

K854084 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT". The FDA issued a decision of Substantially Equivalent on November 8, 1985. The device falls under product code FKL (Insert, Pump, Blood), a Class II device regulated under 21 CFR 876.5820. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1985
Date Received
October 7, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insert, Pump, Blood
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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)

FDA data resources