SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P— 510(k) K850995

Name: FDA 510(k) clearance K850995
Creator: U.S. Food and Drug Administration
Published: 1985-05-10

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K850995 for SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P, Substantially Equivalent on 1985-05-10. Applicant: Awareness Technology, Inc.. Device class: 1.

Clearance details

Applicant: Awareness Technology, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1985-03-11
Decision date: 1985-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

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