HEMOGLOBIN ANALYZER— 510(k) K851467

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K851467 for HEMOGLOBIN ANALYZER, Substantially Equivalent on 1985-07-16. Applicant: Awareness Technology, Inc.. Device class: 2.

Clearance details

Applicant: Awareness Technology, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1985-04-15
Decision date: 1985-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.