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510(k) K852359

AMUCHINA/DIALYZER DISINFECTANT by Amuchina Intl., Inc. — Product Code FKQ

K852359 is an FDA 510(k) premarket notification submitted by Amuchina Intl., Inc. for the device "AMUCHINA/DIALYZER DISINFECTANT". The FDA issued a decision of Substantially Equivalent on May 13, 1986. The device falls under product code FKQ (System, Dialysate Delivery, Central Multiple Patient), a Class II device regulated under 21 CFR 876.5820. Amuchina Intl., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1986
Date Received
June 4, 1985
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 Amuchina Intl., Inc.

  • K992016 — AMUKIN D (January 10, 2000)
  • K952302 — AMUCHINA (July 26, 1995)
  • K871583 — MODIFIED LABELING FOR AMUKIN-50% (July 9, 1987)
  • K862928 — AMUKIN-50% FOR CAPD Y-SET (March 9, 1987)

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)
  • K860336 — HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS (March 4, 1986)

FDA data resources