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510(k) K012547

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION by Di-Chem, Inc. — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 2002
Date Received
August 7, 2001
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 Di-Chem, Inc.

  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)
  • K171015 — Citryte (October 13, 2017)
  • K012328 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER (January 18, 2002)
  • K905217 — FORMASURE TEST REAGENT (April 9, 1991)
  • K823103 — DIALYSATE ADDITIVES-POWDER/LIQUID (November 17, 1982)

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)