PHENYTOIN KIT FLUORESCENCE POLARIZATION— 510(k) K842586

Name: FDA 510(k) clearance K842586
Creator: U.S. Food and Drug Administration
Published: 1984-09-26

Substantially Equivalent

Windsor Laboratories, Inc.

FDA 510(k) clearance K842586 for PHENYTOIN KIT FLUORESCENCE POLARIZATION, Substantially Equivalent on 1984-09-26. Applicant: Windsor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Windsor Laboratories, Inc.
Product code: Code LGR
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1984-07-03
Decision date: 1984-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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