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510(k) K792495

Device
VOLU-SOL URINARY SEDIMENT STAIN
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K792495
Product code
ICF  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-18
Date received
1979-12-04
Regulation
864.1850
Classification name
Crystal Violet For Histology
Medical specialty
Hematology
Review panel
Pathology
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 ICF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K864531TISSUE GRAM STAINSigma Diagnostics, Inc.1986-12-22
K842537VON WILLEBRAND FACTOR ANTIGEN SCREENAmerican Dade1984-10-01
K842730GENTIAN VIOLETE K Ind., Inc.1984-08-03
K821503IRIS URINE STAINIntl. Remote Imaging Systems1982-06-03

Legacy Summary#

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FDA Review#

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