STAT TRACKS— 510(k) K974762

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K974762 for STAT TRACKS, Substantially Equivalent on 1998-01-28. 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: 1997-12-19
Decision date: 1998-01-28
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.