510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012547Substantially Equivalent

Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Solution

Di-Chem, Inc., Champlin MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012547 is the FDA 510(k) clearance record for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION, a class II device, cleared for Di-Chem, Inc. on under FDA product code KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder)). FDA records list 6 510(k) clearances for Di-Chem, Inc., from to . As of , FDA records show one recall naming K012547.

Clearance record

Decision date
Received
(164 days to decision)
Product code
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Di-Chem, Inc. 12297 Ensign Ave. N., Champlin MN
510(k) summary
Statement
Third party review
No

Clearances, product code KPO

Trailing 12 months
2 clearances under product code KPO in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260