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510(k) K990507

Device
ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER
Applicant
ALTHIN BIOPHARM, INC.
510(k) number
K990507
Product code
KPO  
Decision
Substantially Equivalent (SESE)
Decision date
1999-05-07
Date received
1999-02-18
Regulation
876.5820
Classification name
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEAN SAURIOL
Address
3885 Industrial Blvd. Laval, Quebec CA H7L 4S3 H7L 4S3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KPO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, Incoporated2026-08-19
K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLC2026-01-29
K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)Fresenius Medical Care Renal Therapies Group, LLC2025-09-09
K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)Fresenius Medical Care Renal Therapies Group, LLC2025-04-04
K240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and Development2024-07-12
K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC2024-05-10
K233213NxStage PureFlow SolutionNxstage Medical, Inc.2024-01-18
K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504Fresenius Medical Care Renal Therapies Group, LLC2023-12-01
K223431Citric Complete Liquid Citric Acid ConcentrateNipro Renal Solutions USA, Corp.2023-08-04
K221652NIKKICARTRenal Care Dialysis Solutions, S.A. DE C.V.2023-03-03
K202508Hemo-Lyte C CartridgeDi-Chem, Inc.2022-08-12
K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC2022-05-12
K212052HMB32 Dialysis SolutionHaemopharm Biofluids S.R.L.2021-07-23
K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisNipro Renal Solutions USA, Corp.2020-11-25
K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateFresenius Medical Care Renal Therapies Group, LLC2020-05-08

Legacy Summary#

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FDA Review#

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