Cleared Traditional

K994343 - BACT/ALERT SV
(FDA 510(k) Clearance)

K994343 · Organon Teknika Corp. · Microbiology

Feb 2000

Decision

49d

Days

Class 1

Risk

K994343 is an FDA 510(k) clearance for the BACT/ALERT SV, 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 February 10, 2000, 49 days after receiving the submission on December 23, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K994343 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1999
Decision Date	February 10, 2000
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF