Cleared Traditional

DOCUMENT SALICYLATE CAL VER

K041073 · Microgenics Corp. · Chemistry
May 2004
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K041073 is an FDA 510(k) clearance for the DOCUMENT SALICYLATE CAL VER, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on May 21, 2004, 25 days after receiving the submission on April 26, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K041073 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2004
Decision Date May 21, 2004
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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