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510(k) K852117

Device
CYTO-TEK CENTRIFUGE
Applicant
MILES LABORATORIES, INC.
510(k) number
K852117
Product code
IFB  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-10
Date received
1985-05-15
Regulation
864.3300
Classification name
Cytocentrifuge
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN H ENGELMANN
Address
1127 Myrtle St. P.O. Box 40 Elkhart IN US 46514 46514

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IFB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K810848CYTOBUCKET MODEL 1024Cytochem, Inc.1981-04-23
K792032LEIF CENTRIFUGAL CYTOLOGY BUCKETRobert C. Leif, Ph.D.1979-11-30

Legacy Summary#

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FDA Review#

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