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FDA 510(k)

ADR-22 AUTOMATIC DIALYZER REPROCESSOR

K-Number: K874034 · 1987-10-23

ApplicantBiodynamics Corp.
Decision Date1987-10-23
Product CodeLIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ADR-22 AUTOMATIC DIALYZER REPROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K874034. 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 ADR-22 AUTOMATIC DIALYZER REPROCESSOR?

ADR-22 AUTOMATIC DIALYZER REPROCESSOR is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is Biodynamics Corp.. The 510(k) number is K874034.

When did ADR-22 AUTOMATIC DIALYZER REPROCESSOR receive FDA 510(k) clearance?

ADR-22 AUTOMATIC DIALYZER REPROCESSOR received FDA 510(k) clearance on 1987-10-23, under 510(k) number K874034.

Who is the listed applicant for ADR-22 AUTOMATIC DIALYZER REPROCESSOR?

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

What is the FDA product code for ADR-22 AUTOMATIC DIALYZER REPROCESSOR?

The FDA product code for ADR-22 AUTOMATIC DIALYZER REPROCESSOR is LIF.

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Other records listing Biodynamics 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

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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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