CHARISE CHARLES REAGENT BLOOD STRIPS— 510(k) K893894

Name: FDA 510(k) clearance K893894
Creator: U.S. Food and Drug Administration
Published: 1989-07-27

Substantially Equivalent

Lee Import Domestic Consulting

FDA 510(k) clearance K893894 for CHARISE CHARLES REAGENT BLOOD STRIPS, Substantially Equivalent on 1989-07-27. Applicant: Lee Import Domestic Consulting. Device class: 2.

Clearance details

Applicant: Lee Import Domestic Consulting
Product code: Code JIO
Device class: Class 2
Regulation: 21 CFR 864.6550
Advisory panel: Hematology
Date received: 1989-05-30
Decision date: 1989-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

Download summary PDF View on FDA.gov ↗

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