Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE

K-Number: K911771 · 1991-07-01

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1991-07-01
Product CodeLJK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K911771. The device is classified under product code LJK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARD(TM) ANTIMICROBIAL REMOVAL DEVICE?

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K911771.

When did ARD(TM) ANTIMICROBIAL REMOVAL DEVICE receive FDA 510(k) clearance?

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE received FDA 510(k) clearance on 1991-07-01, under 510(k) number K911771.

Who is the listed applicant for ARD(TM) ANTIMICROBIAL REMOVAL DEVICE?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARD(TM) ANTIMICROBIAL REMOVAL DEVICE?

The FDA product code for ARD(TM) ANTIMICROBIAL REMOVAL DEVICE is LJK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003062BACTEC MGIT 960 SIR KITSK0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGEK003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLEK002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16K001364BD DIRECTIGEN FLU A+BK000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: LJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLBoston Biomedica, Inc.K861122THE GOLDEN QUAD TEST (TOXO)Microbiological Research Corp.K861460SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101Widran Urological Group, Ltd.K832069TOXO IPA KIT IAN INDIRECT FLUORESCENTBionetic Laboratory ProductsK822605TOXOPLASMA GONDII ANTIBODY IGGImmulok, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑