FDA 510(k)

QBC E-Z PREP

K-Number: K913399 · 1991-10-18

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1991-10-18

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

QBC E-Z PREP 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 1991-10-18 under 510(k) number K913399. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QBC E-Z PREP?

QBC E-Z PREP is a medical device that received FDA 510(k) clearance on 1991-10-18. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K913399.

When did QBC E-Z PREP receive FDA 510(k) clearance?

QBC E-Z PREP received FDA 510(k) clearance on 1991-10-18, under 510(k) number K913399.

Who is the listed applicant for QBC E-Z PREP?

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 QBC E-Z PREP?

The FDA product code for QBC E-Z PREP is JKA.

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 KITS K0035530.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE K003461BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE K002938B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 K001364BD DIRECTIGEN FLU A+B K000762MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

View all 632 devices →

Related Devices (Code: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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.