INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET— 510(k) K915708

Name: FDA 510(k) clearance K915708
Creator: U.S. Food and Drug Administration
Published: 1992-01-22

Substantially Equivalent

Tech Intl. Co.

FDA 510(k) clearance K915708 for INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET, Substantially Equivalent on 1992-01-22. Applicant: Tech Intl. Co.. Device class: 1.

Clearance details

Applicant: Tech Intl. Co.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1991-11-29
Decision date: 1992-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester Hills, MI, US

Download summary PDF View on FDA.gov ↗

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