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510(k) K844640

Device
POLYSTAT, BIOLOGICAL STAIN
Applicant
SURGIPATH MEDICAL INDUSTRIES, INC.
510(k) number
K844640
Product code
IAB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-01-30
Date received
1984-11-28
Regulation
864.1850
Classification name
Toluidine Blue
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KEN URBAN
Address
P.O. Box 769 Grayslake IL US 60030 60030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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