Cleared Traditional

JAS CALCIUM (ARSENAZO) REAGENT

K011441 · Jas Diagnostics, Inc. · Chemistry
Jul 2001
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K011441 is an FDA 510(k) clearance for the JAS CALCIUM (ARSENAZO) REAGENT, a Azo Dye, Calcium (Class II — Special Controls, product code CJY), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on July 9, 2001, 60 days after receiving the submission on May 10, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K011441 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2001
Decision Date July 09, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CJY — Azo Dye, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145

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