FDA.reportPublic FDA data

510(k) K012152

Device
DS30 HCY BLOOD COLLECTION TUBES
Applicant
Drew Scientific , Ltd.
510(k) number
K012152
Product code
GIM
Decision
Substantially Equivalent (SESE)
Decision date
2001-09-18
Date received
2001-07-11
Regulation
862.1675
Classification name
Tubes, Vacuum Sample, With Anticoagulant
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
ANDREW KENNEY
Address
Park Rd.,Telemeter Bldg. Barrow In Furness GB LA 14 4QR LA 14 4QR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K944814CORVAC PLASTIC BLOOD COLLECTION TUBESherwood Medical Co.1994-12-19
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K933939BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERTOrganon Teknika Corp.1994-02-07
K933386VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1993-10-12
K922858MULTIDRAW SYSTEMCambridge Multi-Draw, Inc.1992-11-16
K922468ANGEL WING SETS -- MODIFIEDMbo Laboratories, Inc.1992-07-10