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FDA 510(k)

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)

K-Number: K050827 · 2005-08-22

ApplicantDialysis Solutions, Inc.
Decision Date2005-08-22
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) is the device name listed in this FDA 510(k) record. The listed applicant is Dialysis Solutions, Inc.. It received FDA 510(k) clearance on 2005-08-22 under 510(k) number K050827. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)?

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) is a medical device that received FDA 510(k) clearance on 2005-08-22. The listed applicant is Dialysis Solutions, Inc.. The 510(k) number is K050827.

When did NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) receive FDA 510(k) clearance?

NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) received FDA 510(k) clearance on 2005-08-22, under 510(k) number K050827.

Who is the listed applicant for NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)?

The FDA 510(k) record lists Dialysis Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)?

The FDA product code for NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE) is KPO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KPO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260799Nipro Dry Acid Concentrate MixerNipro Technical Solutions, IncoporatedK253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)Fresenius Medical Care Renal Therapies Group, LLCK252180Bicarby 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, LLCK243786Bicarby 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, LLCK240920HemoCare Bicarbonate Concentrate Set (BCS)Deka Research and DevelopmentK233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)Fresenius Medical Care Renal Therapies Group, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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