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FDA 510(k)

POWDERED BICARBONATE CONCENTRATE

K-Number: K865078 · 1987-03-27

ApplicantBicarbolyte Corp.
Decision Date1987-03-27
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

POWDERED BICARBONATE CONCENTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Bicarbolyte Corp.. It received FDA 510(k) clearance on 1987-03-27 under 510(k) number K865078. 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 POWDERED BICARBONATE CONCENTRATE?

POWDERED BICARBONATE CONCENTRATE is a medical device that received FDA 510(k) clearance on 1987-03-27. The listed applicant is Bicarbolyte Corp.. The 510(k) number is K865078.

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

POWDERED BICARBONATE CONCENTRATE received FDA 510(k) clearance on 1987-03-27, under 510(k) number K865078.

Who is the listed applicant for POWDERED BICARBONATE CONCENTRATE?

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

What is the FDA product code for POWDERED BICARBONATE CONCENTRATE?

The FDA product code for POWDERED BICARBONATE CONCENTRATE 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

Other records listing Bicarbolyte Corp. as applicant

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.

K843866HEMODIALYSATE SOLUTIONS

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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