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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscope, mirror
510(k) Number K862838
Device Name CYTOTECH HSV IGG ENZYME IMMUNOASSAY
Applicant
CYTOTECH, INC.
11035 ROSELLE STREET, SUITE A
SAN DIEGO,  CA  92121
Applicant Contact BRYAN L KIEHL
Correspondent
CYTOTECH, INC.
11035 ROSELLE STREET, SUITE A
SAN DIEGO,  CA  92121
Correspondent Contact BRYAN L KIEHL
Regulation Number876.1500
Classification Product Code
GCO  
Date Received07/25/1986
Decision Date 12/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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