UNITEST-POTASSIUM— 510(k) K812677

Substantially Equivalent

Biodynamics Corp.

FDA 510(k) clearance K812677 for UNITEST-POTASSIUM, Substantially Equivalent on 1981-10-02. Applicant: Biodynamics Corp.. Device class: 2.

Clearance details

Applicant: Biodynamics Corp.
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1981-09-22
Decision date: 1981-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.