FOCUS-GHB— 510(k) K871679

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K871679 for FOCUS-GHB, Substantially Equivalent on 1987-07-28. Applicant: Awareness Technology, Inc.. Device class: 2.

Clearance details

Applicant: Awareness Technology, Inc.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1987-04-29
Decision date: 1987-07-28
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.