JAS CALCIUM (ARSENAZO) REAGENT— 510(k) K011441

Name: FDA 510(k) clearance K011441
Creator: U.S. Food and Drug Administration
Published: 2001-07-09

Substantially Equivalent

Jas Diagnostics, Inc.

FDA 510(k) clearance K011441 for JAS CALCIUM (ARSENAZO) REAGENT, Substantially Equivalent on 2001-07-09. Applicant: Jas Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Jas Diagnostics, Inc.
Product code: Code CJY
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2001-05-10
Decision date: 2001-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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