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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 St., Suite A
San Diego,  CA  92121
Applicant Contact BRYAN L KIEHL
Correspondent
Cytotech, Inc.
11035 Roselle St., 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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