Bact/Alert CSR

FDA 510(k) K003104 · Organon Teknika Corp.

Substantially Equivalent

510(k) numberK003104

Submission

Device name
Bact/Alert CSR
Applicant
Organon Teknika Corp.
Durham, NC, US
Received
August 29, 2000
Decision date
October 20, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LJF – Device, Antimicrobial Drug Removal
Device class
Class I (low risk)
Regulation
21 CFR 866.2560
Specialty
Microbiology

Other 510(k)s with product code LJF

510(k)DeviceApplicantDecision
K830372Artimicrobial Removal DeviceLJF · Traditional Marion Laboratories, Inc.04/08/1983SE
K830363Bactec 170 Tryptic Soy Broth W/ResinsLJF · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic03/24/1983SE
K822344Antimicrobial Removal Device (Ard)LJF · Traditional Marion Laboratories, Inc.08/25/1982SE

More from Marion Laboratories, Inc.

510(k)DeviceDecision
K000492Mda D-DimerDAP · Traditional 06/07/2000SE
K000378Bact/Alert MB Culture BottleMDB · Traditional 03/02/2000SE
K994343Bact/Alert SVMDB · Traditional 02/10/2000SE
K993423Bact/Alert SAMDB · Traditional 12/15/1999SE
K993576Bact/Alert MP Process BottleMDB · Traditional 12/14/1999SE
K993421Bact/Alert SNMDB · Traditional 12/14/1999SE
K992432Bact/Alert FNMDB · Traditional 09/24/1999SE
K983762Nuclisens CMV PP67LIN · Traditional 09/15/1999SE
K992401Bact/Alert PFMDB · Traditional 09/03/1999SE
K992400Bactalert FaMDB · Traditional 09/03/1999SE

Questions and answers

When was Bact/Alert CSR cleared by the FDA?

Bact/Alert CSR (K003104) received a 510(k) decision of Substantially Equivalent on October 20, 2000, 52 days after the submission was received.

What is the product code of K003104?

The FDA product code is LJF – Device, Antimicrobial Drug Removal, a Class I (low risk) device regulated under 21 CFR 866.2560.