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510(k) K842513

HEMOPERFUSION PROCEDURE W/REDY 2000 by Organon Teknika Corp. — Product Code FKT

K842513 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "HEMOPERFUSION PROCEDURE W/REDY 2000". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code FKT (System, Dialysate Delivery, Sorbent Regenerated), a Class II device regulated under 21 CFR 876.5600. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1984
Date Received
June 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sorbent Regenerated
Device Class
Class II
Regulation Number
876.5600
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)

Other clearances for product code FKT

  • K123835 — 2008 HEMODIALYSIS SORBENT SYSTEM (February 15, 2013)
  • K093362 — 2008 HEMODIALYSIS SORBENT SYSTEM (August 13, 2010)
  • K070739 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500 (May 25, 2007)
  • K060381 — ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100 (May 24, 2006)
  • K043574 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 (June 3, 2005)
  • K031099 — SORB+HISORB+CARTRIDGE (September 17, 2003)
  • K954623 — REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNE (August 28, 1996)
  • K882428 — REDY 2000 (October 25, 1988)
  • K874137 — MODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CAR (April 8, 1988)
  • K870270 — MODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART. (February 25, 1987)

FDA data resources