JAS AMYLASE LIQUID REAGENT— 510(k) K020282

Name: FDA 510(k) clearance K020282
Creator: U.S. Food and Drug Administration
Published: 2002-02-28

Substantially Equivalent

Jas Diagnostics, Inc.

FDA 510(k) clearance K020282 for JAS AMYLASE LIQUID REAGENT, Substantially Equivalent on 2002-02-28. Applicant: Jas Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Jas Diagnostics, Inc.
Product code: Code JFJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 2002-01-28
Decision date: 2002-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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