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FDA 510(k)

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS

K-Number: K880102 · 1988-05-26

ApplicantBaxter Healthcare Corp
Decision Date1988-05-26
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIASOL CONCENTRATES FOR BICARBONATE 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 1988-05-26 under 510(k) number K880102. 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 CONCENTRATES FOR BICARBONATE DIALYSIS?

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS is a medical device that received FDA 510(k) clearance on 1988-05-26. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K880102.

When did BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS receive FDA 510(k) clearance?

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS received FDA 510(k) clearance on 1988-05-26, under 510(k) number K880102.

Who is the listed applicant for BIASOL CONCENTRATES FOR BICARBONATE 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 CONCENTRATES FOR BICARBONATE DIALYSIS?

The FDA product code for BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS is KPO.

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Other records listing Baxter Healthcare Corp as applicant

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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

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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