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510(k) K844734

ALCIDE REN NEW-D by Alcide Corp. — Product Code FKQ

K844734 is an FDA 510(k) premarket notification submitted by Alcide Corp. for the device "ALCIDE REN NEW-D". The FDA issued a decision of Substantially Equivalent on May 17, 1985. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Alcide Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1985
Date Received
December 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Central Multiple Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Alcide Corp.

  • K952929 — LD GENERAL PURPOSE DISINFECTANT (October 7, 1995)
  • K953241 — EXSPOR (September 29, 1995)
  • K853413 — RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS (September 6, 1985)

Other clearances for product code FKQ

  • K052764 — DIACAP ULTRA DIALYSIS FLUID FILTER (June 9, 2006)
  • K893612 — TWO TANK DISSOLUTION MODULE (July 24, 1989)
  • K874084 — MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (April 27, 1988)
  • K873421 — KAWASUMI A.V. FISTULA SET (October 9, 1987)
  • K870889 — ACID FUCHSIN SOLUTIONS (July 8, 1987)
  • K861730 — ACTRIL FOR KIDNEY MACHINE DISINFECTANT (June 9, 1987)
  • K864635 — FOUR TANK DISSOLUTION MODULE (January 13, 1987)
  • K862304 — DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (September 9, 1986)
  • K861472 — MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (July 10, 1986)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

FDA data resources