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FDA 510(k)

HAEMODIALYSIS CONCENTRATE

K-Number: K904946 · 1991-04-09

ApplicantBdh, Inc.
Decision Date1991-04-09
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HAEMODIALYSIS CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Bdh, Inc.. It received FDA 510(k) clearance on 1991-04-09 under 510(k) number K904946. 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 HAEMODIALYSIS CONCENTRATE?

HAEMODIALYSIS CONCENTRATE is a medical device that received FDA 510(k) clearance on 1991-04-09. The listed applicant is Bdh, Inc.. The 510(k) number is K904946.

When did HAEMODIALYSIS CONCENTRATE receive FDA 510(k) clearance?

HAEMODIALYSIS CONCENTRATE received FDA 510(k) clearance on 1991-04-09, under 510(k) number K904946.

Who is the listed applicant for HAEMODIALYSIS CONCENTRATE?

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

What is the FDA product code for HAEMODIALYSIS CONCENTRATE?

The FDA product code for HAEMODIALYSIS CONCENTRATE is KPO.

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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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