Multidraw System

FDA 510(k) K922858 · Cambridge Multi-Draw, Inc.

Unknown

510(k) numberK922858

Submission

Device name
Multidraw System
Applicant
Cambridge Multi-Draw, Inc.
Cambridge, MA, US
Received
June 15, 1992
Decision date
November 16, 1992
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GIM – Tubes, Vacuum Sample, With Anticoagulant
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Specialty
Clinical Chemistry

Other 510(k)s with product code GIM

510(k)DeviceApplicantDecision
K240455BD Vacutainer® Citrate Blood Collection TubesGIM · Traditional Becton, Dickinson and Company10/31/2024SE
K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood…GIM · Traditional Becton, Dickinson and Company11/27/2023SE
K213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesGIM · Traditional Becton, Dickinson and Company08/25/2023SE
K162723TransFix/EDTA Vacuum Blood Collection TubesGIM · Traditional Caltag Medsystems, Ltd.06/22/2017SE
K080552Cyto-Chex BCTGIM · Traditional Streck07/31/2008SE
K012152DS30 Hcy Blood Collection TubesGIM · Traditional Drew Scientific , Ltd.09/18/2001SE
K971449Vacutainer Brand Plus Tube with Edta Anticoagulant(Multiple)GIM · Traditional Becton Dickinson Vacutainer Systems06/17/1997SE
K971221Greiner Vacuette Blood Collection TubeGIM · Traditional Greiner America, Inc.05/02/1997SE
K951886Lok-On Needle Disposal SystemGIM · Traditional Becton Dickinson Vacutainer Systems06/30/1995SE
K945458Vacutainer Brand Safety-Gard Phlebotomy SystemGIM · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic02/06/1995SE

Questions and answers

When was Multidraw System cleared by the FDA?

Multidraw System (K922858) received a 510(k) decision of Unknown on November 16, 1992, 154 days after the submission was received.

What is the product code of K922858?

The FDA product code is GIM – Tubes, Vacuum Sample, With Anticoagulant, a Class II (moderate risk) device regulated under 21 CFR 862.1675.