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510(k) K812212

Device
ACRIDINE ORANGE STAIN
Applicant
CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
510(k) number
K812212
Product code
IDC  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-01
Date received
1981-08-05
Regulation
864.1850
Classification name
Acridine Orange
Medical specialty
Hematology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

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
K803304ACRIDINE ORANGE STAINRemel Co.1981-02-12
K810040ACRIDINE ORANGE STAINBd Becton Dickinson Vacutainer Systems Preanalytic1981-02-12

Legacy Summary#

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FDA Review#

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