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FDA 510(k)

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER

K-Number: K012328 · 2002-01-18

ApplicantDi-Chem, Inc.
Decision Date2002-01-18
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Di-Chem, Inc.. It received FDA 510(k) clearance on 2002-01-18 under 510(k) number K012328. 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 HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER?

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER is a medical device that received FDA 510(k) clearance on 2002-01-18. The listed applicant is Di-Chem, Inc.. The 510(k) number is K012328.

When did HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER receive FDA 510(k) clearance?

HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER received FDA 510(k) clearance on 2002-01-18, under 510(k) number K012328.

Who is the listed applicant for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER?

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

What is the FDA product code for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER?

The FDA product code for HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE 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

Other records listing Di-Chem, Inc. 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.

K202508Hemo-Lyte C CartridgeK171015CitryteK012547HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONK905217FORMASURE TEST REAGENTK823103DIALYSATE ADDITIVES-POWDER/LIQUID

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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