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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name complement c1q, antigen, antiserum, control
510(k) Number K862649
Device Name CYTOTECH CIC 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 Number866.5240
Classification Product Code
DAK  
Date Received07/11/1986
Decision Date 09/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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