Atlas FDA

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION

FDA 510(k) clearance K012547 · decided 2002-01-18

Clearance details

K-number
K012547
Device name
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
Applicant
Di-Chem, Inc.
Decision
Substantially Equivalent
Date received
2001-08-07
Decision date
2002-01-18
Days to decision
164 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Champlin, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Pla recall (Z-1730-2025)Nipro Renal Soultions USA, Corporation2025-05-14