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FDA 510(k)

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF

K-Number: K833252 · 1983-12-14

ApplicantErika, Inc.
Decision Date1983-12-14
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF is the device name listed in this FDA 510(k) record. The listed applicant is Erika, Inc.. It received FDA 510(k) clearance on 1983-12-14 under 510(k) number K833252. 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 ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF?

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF is a medical device that received FDA 510(k) clearance on 1983-12-14. The listed applicant is Erika, Inc.. The 510(k) number is K833252.

When did ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF receive FDA 510(k) clearance?

ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF received FDA 510(k) clearance on 1983-12-14, under 510(k) number K833252.

Who is the listed applicant for ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF?

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

What is the FDA product code for ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF?

The FDA product code for ERIKA DI-ALA-KIT-SINGLE DIALYSIS ON/OF is KOC.

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Other records listing Erika, 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.

K853134NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8K852310NATURALYTE BICARBONATE CONCENTRATE-DRY PACKK852309ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1K850866TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1LK850865TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-K850654TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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