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510(k) K882501

Device
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
Applicant
TERUMO MEDICAL CORP.
510(k) number
K882501
Product code
GIM  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-18
Date received
1988-06-17
Regulation
862.1675
Classification name
Tubes, Vacuum Sample, With Anticoagulant
Medical specialty
Clinical Chemistry
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ALAN B HERSHMAN
Address
125 Blue Ball Rd. Elkton MD US 21921 21921

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GIM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company2024-10-31
K230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and Company2023-11-27
K213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson and Company2023-08-25
K162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd.2017-06-22
K080552CYTO-CHEX BCTStreck2008-07-31
K012152DS30 HCY BLOOD COLLECTION TUBESDrew Scientific , Ltd.2001-09-18
K971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)Becton Dickinson Vacutainer Systems1997-06-17
K971221GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.1997-05-02
K951886LOK-ON NEEDLE DISPOSAL SYSTEMBecton Dickinson Vacutainer Systems1995-06-30
K945458VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic1995-02-06
K944814CORVAC PLASTIC BLOOD COLLECTION TUBESherwood Medical Co.1994-12-19
K940058MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPERSherwood Medical Co.1994-05-02
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

Legacy Summary#

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FDA Review#

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