Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER

K-Number: K990507 · 1999-05-07

ApplicantAlthin Biopharm, Inc.
Decision Date1999-05-07
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Althin Biopharm, Inc.. It received FDA 510(k) clearance on 1999-05-07 under 510(k) number K990507. 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 ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER?

ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER is a medical device that received FDA 510(k) clearance on 1999-05-07. The listed applicant is Althin Biopharm, Inc.. The 510(k) number is K990507.

When did ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER receive FDA 510(k) clearance?

ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER received FDA 510(k) clearance on 1999-05-07, under 510(k) number K990507.

Who is the listed applicant for ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER?

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

What is the FDA product code for ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER?

The FDA product code for ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER is KPO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑