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510(k) K862838

Device
CYTOTECH HSV IGG ENZYME IMMUNOASSAY
Applicant
CYTOTECH, INC.
510(k) number
K862838
Product code
GCO  
Decision
Substantially Equivalent (SESE)
Decision date
1986-12-09
Date received
1986-07-25
Regulation
876.1500
Classification name
Endoscope, Mirror
Medical specialty
Gastroenterology/Urology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRYAN L KIEHL
Address
11035 Roselle St., Suite A San Diego CA US 92121 92121

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862717HAND MIRROR (ENDOSCOPE)Simpson/Basye, Inc.1986-07-30
K790340DELTA-ROLJohnson & Johnson Professionals, Inc.1979-04-12

Legacy Summary#

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FDA Review#

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