Cleared Traditional

BACT/ALERT CSR

K003104 · Organon Teknika Corp. · Microbiology

Oct 2000

Decision

52d

Days

Class 1

Risk

About This 510(k) Submission

K003104 is an FDA 510(k) clearance for the BACT/ALERT CSR, a Device, Antimicrobial Drug Removal (Class I — General Controls, product code LJF), submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on October 20, 2000, 52 days after receiving the submission on August 29, 2000. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2560.

Submission Details

510(k) Number	K003104 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 29, 2000
Decision Date	October 20, 2000
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF