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510(k) K130511

CITRISOL ACID CONCENTRATE by Diasol, Inc. — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2014
Date Received
February 27, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Diasol, Inc.

  • K020231 — DIASOL-ADDITIVES (October 21, 2002)
  • K020230 — DIASOL-BICARB (April 23, 2002)
  • K011004 — NEEDLELOK HYPODERMIC NEEDLE PROTECTION (May 24, 2001)
  • K010958 — FISTULOK FISTULA NEEDLE PROTECTION (May 18, 2001)
  • K011003 — SAFESTING AND SAFESTING HUB (April 20, 2001)
  • K992999 — DAISY PROTECTED SCALP VEIN SET (November 5, 1999)
  • K993187 — SHELLY PROTECTED AV FISTULA NEEDLE (November 5, 1999)
  • K992653 — SHELLY PROTECTED AV FISTULA NEEDLE (October 27, 1999)
  • K993212 — DRYASOL ACID CONCENTRATE MIX (October 22, 1999)

Other clearances for product code KPO

  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)