Cleared Traditional

GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL

K862642 · American Micro Scan · Microbiology
Sep 1986
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K862642 is an FDA 510(k) clearance for the GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL, a Gram Negative Identification Panel (Class I — General Controls, product code LQM), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on September 11, 1986, 62 days after receiving the submission on July 11, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K862642 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1986
Decision Date September 11, 1986
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQM — Gram Negative Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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