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510(k) K810040

Device
Acridine Orange Stain
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
510(k) number
K810040
Product code
IDC
Decision
Substantially Equivalent (SESE)
Decision date
1981-02-12
Date received
1981-01-09
Regulation
864.1850
Classification name
Acridine Orange
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
1875 Eye St. NW Suite 625 Washington DC US 20006 20006

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IDC#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853187ACRIDINE ORANGE FLUORESCENT STAINAdvanced Medical Technology, Inc.1985-08-13
K812212ACRIDINE ORANGE STAINCarr-Scarborough Microbiologicals, Inc.1981-09-01
K803304ACRIDINE ORANGE STAINRemel Co.1981-02-12