AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)— 510(k) K972297

Name: FDA 510(k) clearance K972297
Creator: U.S. Food and Drug Administration
Published: 1997-07-17

Substantially Equivalent

Trace America, Inc.

FDA 510(k) clearance K972297 for AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST), Substantially Equivalent on 1997-07-17. Applicant: Trace America, Inc.. Device class: 2.

Clearance details

Applicant: Trace America, Inc.
Product code: Code JFJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1997-06-19
Decision date: 1997-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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