Product Code: LJF FDA class 1 21 CFR 866.2560

Device, Antimicrobial Drug Removal

Microbiology

An antimicrobial drug removal device is a microbiology laboratory tool used to neutralize or remove residual antimicrobial agents from patient blood or other specimens prior to culture, preventing antibiotic carryover from inhibiting bacterial growth and thereby improving the sensitivity of microbiological cultures. The device is FDA Class 1, the lowest risk category, requiring only general controls and exempt from premarket notification. It carries product code LJF and is regulated under 21 CFR 866.2560 within the Microbiology specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: LJF
Device Class: FDA class 1
Regulation Number: 866.2560
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 4 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K003104	BACT/ALERT CSR	Oct 20, 2000	Substantially Equivalent	Organon Teknika Corp.
K830372	ARTIMICROBIAL REMOVAL DEVICE	Apr 08, 1983	Substantially Equivalent	Marion Laboratories, Inc.
K830363	BACTEC 170 TRYPTIC SOY BROTH W/RESINS	Mar 24, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K822344	ANTIMICROBIAL REMOVAL DEVICE (ARD)	Aug 25, 1982	Substantially Equivalent	Marion Laboratories, Inc.