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FDA 510(k)

BICARBOLYTE HEMO-DIAL

K-Number: K833896 · 1984-01-03

ApplicantEdlaw Pharmaceuticals, Inc.
Decision Date1984-01-03
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BICARBOLYTE HEMO-DIAL is the device name listed in this FDA 510(k) record. The listed applicant is Edlaw Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1984-01-03 under 510(k) number K833896. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICARBOLYTE HEMO-DIAL?

BICARBOLYTE HEMO-DIAL is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Edlaw Pharmaceuticals, Inc.. The 510(k) number is K833896.

When did BICARBOLYTE HEMO-DIAL receive FDA 510(k) clearance?

BICARBOLYTE HEMO-DIAL received FDA 510(k) clearance on 1984-01-03, under 510(k) number K833896.

Who is the listed applicant for BICARBOLYTE HEMO-DIAL?

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

What is the FDA product code for BICARBOLYTE HEMO-DIAL?

The FDA product code for BICARBOLYTE HEMO-DIAL is KOC.

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Other records listing Edlaw Pharmaceuticals, 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.

K813388HEMODIALYSATEK811706LACTIC ACID DIALYSATE ADDITIVE

Related Devices (Code: KOC)

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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUNIKKISO CO., LTD.K242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)NIKKISO CO., LTD.K231589Blood Tubing Lines for Hemodialysis AV06C-ENIKKISO CO., LTD.K230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesNIKKISO CO., LTD.K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineFresenius Medical Care Renal Therapies Group, LLCK172238CAREline Airless Hemodialysis Blood Tubing SetsFresenius 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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