Cleared Traditional

BACT/ALERT SA

K993423 · Organon Teknika Corp. · Microbiology
Dec 1999
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K993423 is an FDA 510(k) clearance for the BACT/ALERT SA, a System, Blood Culturing (Class I — General Controls, product code MDB), submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on December 15, 1999, 64 days after receiving the submission on October 12, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number K993423 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1999
Decision Date December 15, 1999
Days to Decision 64 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MDB — System, Blood Culturing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2560

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