Atlas FDA

ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS

FDA 510(k) clearance K954527 · decided 1996-03-01

Clearance details

K-number
K954527
Device name
ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS
Applicant
Rockwell Medical Supply
Decision
Substantially Equivalent
Date received
1995-09-29
Decision date
1996-03-01
Days to decision
154 days
Clearance type
Traditional
Product code
KPO
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Wixom, MI, US
Third-party review
No
Expedited review
No

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NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462)Fresenius Medical Care Renal Therapies Group, LLC2026-01-29
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pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (K233950)Fresenius Medical Care Renal Therapies Group, LLC2024-05-10
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pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (K233159)Fresenius Medical Care Renal Therapies Group, LLC2023-12-01
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Recalls involving this device

RecordFirmDate
RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwel recall (Z-0871-2008)Rockwell Medical Technologies, Inc2008-02-13
RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwel recall (Z-0872-2008)Rockwell Medical Technologies, Inc2008-02-13
RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwel recall (Z-0873-2008)Rockwell Medical Technologies, Inc2008-02-13