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510(k) K855212

ASAHI AM SERIES DIALYZERS by Advocacy International, Ltd. — Product Code FJI

K855212 is an FDA 510(k) premarket notification submitted by Advocacy International, Ltd. for the device "ASAHI AM SERIES DIALYZERS". The FDA issued a decision of Substantially Equivalent on January 21, 1986. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Advocacy International, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1986
Date Received
December 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Advocacy International, Ltd.

  • K874027 — LIPASE UV [TOYO] (May 27, 1988)
  • K873792 — SEPACELL R-500 AND SEPACELL R-500A (January 19, 1988)
  • K855251 — MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS (February 4, 1986)
  • K854259 — SEPACELL R-500 & SEPACELL R-500A (January 8, 1986)
  • K842103 — TOYO JOZO URIC ACID TEST (August 12, 1984)
  • K842104 — TOYO JOZO G-GTP TEST (August 10, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)
  • K813037 — FLOWGUARD CATHETERS & CANNALAE (December 14, 1981)

Other clearances for product code FJI

  • K190459 — Hemoflow F3 and F4 Dialyzers (August 23, 2019)
  • K122952 — NIPRO PUREFLUX-L HEMODIALYZER (December 4, 2013)
  • K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS (May 27, 2005)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (December 4, 2000)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)

FDA data resources