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FDA 510(k)

BICARBONATE CONCENTRATE POWDER

K-Number: K891921 · 1989-04-17

ApplicantHaemolyte, Inc.
Decision Date1989-04-17
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BICARBONATE CONCENTRATE POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Haemolyte, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K891921. 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 BICARBONATE CONCENTRATE POWDER?

BICARBONATE CONCENTRATE POWDER is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Haemolyte, Inc.. The 510(k) number is K891921.

When did BICARBONATE CONCENTRATE POWDER receive FDA 510(k) clearance?

BICARBONATE CONCENTRATE POWDER received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891921.

Who is the listed applicant for BICARBONATE CONCENTRATE POWDER?

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

What is the FDA product code for BICARBONATE CONCENTRATE POWDER?

The FDA product code for BICARBONATE CONCENTRATE POWDER 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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