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FDA 510(k)

WAREXIN RECOMMENDED ALTERNATIVE DIALYZ

K-Number: K843520 · 1984-10-04

ApplicantMesa Medical, Inc.
Decision Date1984-10-04
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WAREXIN RECOMMENDED ALTERNATIVE DIALYZ is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Medical, Inc.. It received FDA 510(k) clearance on 1984-10-04 under 510(k) number K843520. The device is classified under product code LIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAREXIN RECOMMENDED ALTERNATIVE DIALYZ?

WAREXIN RECOMMENDED ALTERNATIVE DIALYZ is a medical device that received FDA 510(k) clearance on 1984-10-04. The listed applicant is Mesa Medical, Inc.. The 510(k) number is K843520.

When did WAREXIN RECOMMENDED ALTERNATIVE DIALYZ receive FDA 510(k) clearance?

WAREXIN RECOMMENDED ALTERNATIVE DIALYZ received FDA 510(k) clearance on 1984-10-04, under 510(k) number K843520.

Who is the listed applicant for WAREXIN RECOMMENDED ALTERNATIVE DIALYZ?

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

What is the FDA product code for WAREXIN RECOMMENDED ALTERNATIVE DIALYZ?

The FDA product code for WAREXIN RECOMMENDED ALTERNATIVE DIALYZ is LIF.

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Other records listing Mesa Medical, 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.

K92521090DX MULTITEST METER, MODIFICATIONK882032MODEL 90DX MULTITEST METERK870811MODEL 102 PH METERK852749RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANTK834447ECHO MM1000K821383ECHO, MODEL MM-1000

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Related Devices (Code: LIF)

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.

K091360CLEARFLUX DIALYZER REPROCESSING SYSTEMNovaflux TechnologiesK043126ASSIST HEADER CLEANERAlcavis International, Inc.K040660STERICHEK GLUTARALDEHYDE REAGENT STRIPSHach CompanyK033505RENACLEAN SH DIALYZER CLEANING SYSTEMMinntech Corp.K024076MAKY 21.1 DIALYZER REPROCESSING SYSTEMHdc Maquinolas, LLCK013713ARM AUTOMATIC REPROCESSING MACHINEAlcavis International Incorporated

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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