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510(k) K885091

Device
HEMAVIEW DARKFIELD MICROSCOPE SYSTEM
Applicant
TECHNALYSIS, INC.
510(k) number
K885091
Product code
IBM  
Decision
Substantially Equivalent (SESE)
Decision date
1989-06-13
Date received
1988-12-12
Regulation
864.3600
Classification name
Microscope, Phase Contrast
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY J KATKE
Address
23180 Del Lago Laguna Hills CA US 92653 92653

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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