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510(k) K890042

Device
MICROSCOPE SLIDES PRECOATED
Applicant
STAT PATH
510(k) number
K890042
Product code
KEW  
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-13
Date received
1989-01-05
Regulation
864.3010
Classification name
Slides, Microscope
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ELIZABETH BOSTWICK
Address
P.O. Box 6 Riderwood MD US 21139 21139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KEW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891604THE CEN-SLIDE(TM) CENTRIFUGE TUBEDavstar California, Inc.1989-06-16
K882357MICROSCOPE SLIDES PRECOATED W/HISTOGRIP & POLY-LYStat Path1988-06-16
K831065SECTIONING AID KITTechnicon Instruments Corp.1983-06-08
K820100FROSTED GLASS SLIDESStan-Pak Ent.1982-03-04
K813242QUANTIMETRIC 2 TEST KITKallestad Laboratories, Inc.1981-12-02
K800232ABCO ULTRA SLIDE MICROSCOPE SLIDEAbco Dealers, Inc.1980-02-21
K760278SLIDE, LAB-TEK COVERED MICROMiles Laboratories, Inc.1976-08-30

Legacy Summary#

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FDA Review#

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