CHARISE CHARLES REAGENT STRIPS— 510(k) K895282

Name: FDA 510(k) clearance K895282
Creator: U.S. Food and Drug Administration
Published: 1990-01-10

Substantially Equivalent

Lee Import Domestic Consulting

FDA 510(k) clearance K895282 for CHARISE CHARLES REAGENT STRIPS, Substantially Equivalent on 1990-01-10. Applicant: Lee Import Domestic Consulting. Device class: 2.

Clearance details

Applicant: Lee Import Domestic Consulting
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 1989-08-24
Decision date: 1990-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

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