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FDA 510(k)

UNITEST-POTASSIUM

K-Number: K812677 · 1981-10-02

ApplicantBiodynamics Corp.
Decision Date1981-10-02
Product CodeCEJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNITEST-POTASSIUM is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812677. The device is classified under product code CEJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITEST-POTASSIUM?

UNITEST-POTASSIUM is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Biodynamics Corp.. The 510(k) number is K812677.

When did UNITEST-POTASSIUM receive FDA 510(k) clearance?

UNITEST-POTASSIUM received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812677.

Who is the listed applicant for UNITEST-POTASSIUM?

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 UNITEST-POTASSIUM?

The FDA product code for UNITEST-POTASSIUM is CEJ.

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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: CEJ)

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.

K043267POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2Randox Laboratories, Ltd.K943026POTASSIUM QVETPrisma SystemsK904033REFLOTRON POTASSIUM TEST TABSBoehringer Mannheim Corp.K902574POTASSIUM REAGENT SETTech-Co, Inc.K883586TECHNICON RA-100 SYSTEM POTASSIUMTechnicon Instruments Corp.K883585TECHNICON ASSIST POTASSIUMTechnicon Instruments Corp.

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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