Cleared Traditional

K000378 - BACT/ALERT MB CULTURE BOTTLE
(FDA 510(k) Clearance)

K000378 · Organon Teknika Corp. · Microbiology

Mar 2000

Decision

24d

Days

Class 1

Risk

K000378 is an FDA 510(k) clearance for the BACT/ALERT MB CULTURE BOTTLE, 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 March 2, 2000, 24 days after receiving the submission on February 7, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K000378 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2000
Decision Date	March 02, 2000
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF