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FDA 510(k)

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

K-Number: K011368 · 2001-08-02

ApplicantGambro Renal Products
Decision Date2001-08-02
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Renal Products. It received FDA 510(k) clearance on 2001-08-02 under 510(k) number K011368. 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 DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS?

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2001-08-02. The listed applicant is Gambro Renal Products. The 510(k) number is K011368.

When did DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS receive FDA 510(k) clearance?

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS received FDA 510(k) clearance on 2001-08-02, under 510(k) number K011368.

Who is the listed applicant for DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS?

The FDA 510(k) record lists Gambro Renal Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS?

The FDA product code for DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS is KPO.

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Other records listing Gambro Renal Products as applicant

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.

K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYK072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYK070414GAMBRO CARTRIDGE BLOOD SETSK063290GAMBRO QUICKSET BLOODLINESK062090PRISMA SYSTEM R03.10AK060195GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE

View all 24 devices →

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

View on FDA Database →

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

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