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Panels › Gastroenterology, Urology › Product code KPO · Class 2

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

Regulation 876.5820

2510(k)s in 12 months (124 all time)
15recalls in 12 months (113 all time)
113recalls that name a 510(k)
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Top companies in KPO

Company510(k)sRecalls
Fresenius Medical Care Holdings, Inc.059
Fresenius Medical Care Renal Therapies Group, LLC1012
Nxstage Medical, Inc.615
Diasol, Inc.48
Rockwell Medical Technologies, Inc.57
Baxter Healthcare Corp71
Gambro Renal Products60
Nipro Renal Soultions USA, Corporation06
Di-Chem, Inc.50
Isopure, Corp.23
Decided510(k)Device and applicantCode
Mar 10, 1987K864942BICARBONATE MIXING SYSTEM
Morris Tool , Ltd.
KPO
Oct 16, 1986K863631SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
American Healthcare Corp.
KPO
Sep 23, 1986K861156HOSPAL DIALYSATE FOR CAVHD
Hospal Medical Corp.
KPO
Feb 5, 1986K852955HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD
Renalchem, Inc.
KPO
Oct 31, 1985K854206ULTRACLONE 05-100 GUINEA PIG RBC
Earl-Clay Laboratories, Inc.
KPO
Jun 12, 1985K851431HEMODIALYSIS CONCENTRATE ADDITIVES
Dana Laboratories
KPO
Jan 9, 1985K843866HEMODIALYSATE SOLUTIONS
Bicarbolyte Corp.
KPO
Feb 21, 1984K834538LAS-2 ALIGNMENT SYSTEM
Therados, Inc.
KPO
Nov 3, 1983K832866HEMO-DIAL
Cmi Pharmaceuticals, Inc.
KPO
Jan 17, 1983K823779DIALYTE
Renal Dynamics, Inc.
KPO
Nov 17, 1982K823103DIALYSATE ADDITIVES-POWDER/LIQUID
Di-Chem, Inc.
KPO
May 18, 1982K821304CENTRALYTE BICARBONATE CONCENTRATE
Erika, Inc.
KPO
Jan 29, 1982K820150K-AID
Sytek Laboratories
KPO
Jan 29, 1982K813586DIALYSIS CONCENTRATE
Diversified Medical Services
KPO
Dec 31, 1981K813388HEMODIALYSATE
Edlaw Pharmaceuticals, Inc.
KPO
Sep 24, 1981K811706LACTIC ACID DIALYSATE ADDITIVE
Edlaw Pharmaceuticals, Inc.
KPO
Apr 23, 1981K810925NATURALYTE BICARBONATE DIALYSATE CONCEN.
Erika, Inc.
KPO
Apr 23, 1981K810527CHEM-DIALYTE CONCENTRATES
Luchem Pharmaceuticals, Inc.
KPO
Feb 19, 1981K810280DIALYSATE CONCENTRATE FOR HEMODIALYSIS
Cobe Laboratories, Inc.
KPO
Jul 14, 1980K800624LOW-ACETATE HEMODIALYSIS BATH CONCENTR.
Travenol Laboratories, S.A.
KPO
Apr 8, 1980K792513HEMODIALYSIS CONCENTRATE SOLUTION
Mid Atlantic Nephrology Center
KPO
Jan 4, 1980K792213RENAL SYSTEMS HEMODIALYSIS CONCENTRATE
Renal Systems, Inc.
KPO
Dec 7, 1978K781967HEMODIALYSIS CONCENTRATE, SODIU
Renal Systems, Inc.
KPO
Apr 5, 1978K780353DRI-LYTE
Mallinckrodt Critical Care
KPO

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