GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)— 510(k) K980026

Name: FDA 510(k) clearance K980026
Creator: U.S. Food and Drug Administration
Published: 1998-03-10

Substantially Equivalent

Trace America, Inc.

FDA 510(k) clearance K980026 for GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), Substantially Equivalent on 1998-03-10. Applicant: Trace America, Inc.. Device class: 2.

Clearance details

Applicant: Trace America, Inc.
Product code: Code CFR
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 1998-01-05
Decision date: 1998-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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