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510(k) K800323

Device
VOLU-SOL ORANGE G-6 STAIN
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K800323
Product code
HZH  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-22
Date received
1980-02-12
Regulation
864.1850
Classification name
Orange G
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 HZH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842924ORANGE G, 1%E K Ind., Inc.1984-09-07
K822038VOLU-SOL ORANGE G-6(GILLS-MODVolu Sol Medical Industries1982-08-03
K811825ORANGE G-6Surgipath1981-07-10

Legacy Summary#

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FDA Review#

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