Cleared Traditional

GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL

K863038 · American Micro Scan · Microbiology
Sep 1986
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K863038 is an FDA 510(k) clearance for the GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL, a Gram Positive Identification Panel (Class I — General Controls, product code LQL), submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on September 30, 1986, 49 days after receiving the submission on August 12, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K863038 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date September 30, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LQL — Gram Positive Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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