Cleared Traditional

QUANTIMETRIX AMMONIA CONTROLS

K913346 · Quantimetrix Corp. · Chemistry
Sep 1991
Decision
61d
Days
Class 1
Risk

About This 510(k) Submission

K913346 is an FDA 510(k) clearance for the QUANTIMETRIX AMMONIA CONTROLS, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on September 25, 1991, 61 days after receiving the submission on July 26, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K913346 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1991
Decision Date September 25, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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