Cleared Traditional

SCEPTOR IDENTIFICATION SYSTEM

K912897 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology
Oct 1991
Decision
119d
Days
Class 1
Risk

About This 510(k) Submission

K912897 is an FDA 510(k) clearance for the SCEPTOR IDENTIFICATION SYSTEM, a Gram Negative Identification Panel (Class I — General Controls, product code LQM), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 28, 1991, 119 days after receiving the submission on July 1, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K912897 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1991
Decision Date October 28, 1991
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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