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FDA 510(k)

BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS

K-Number: K884725 · 1989-01-30

ApplicantBaxter Healthcare Corp
Decision Date1989-01-30
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884725. 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 BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS?

BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K884725.

When did BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS receive FDA 510(k) clearance?

BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884725.

Who is the listed applicant for BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS?

The FDA product code for BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS 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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