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510(k) K842302

FLUID WARMER by Organon Teknika Corp. — Product Code FLA

K842302 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "FLUID WARMER". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code FLA (Monitor, Temperature, Dialysis), 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
August 27, 1984
Date Received
June 11, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Temperature, Dialysis
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)

Other clearances for product code FLA

  • K140623 — NXSTAGE EXPRESS FLUID WARMER (June 16, 2014)
  • K810021 — FLO-TEMP (January 23, 1981)

FDA data resources