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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C1s, Antigen, Antiserum, Control
510(k) Number K874379
Device Name CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
Applicant
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Applicant Contact KIEHL, PHD
Correspondent
Cytotech, Inc.
11035 Roselle St., Suite A
San Diego,  CA  92121
Correspondent Contact KIEHL, PHD
Regulation Number866.5240
Classification Product Code
CZY  
Date Received10/26/1987
Decision Date 11/25/1987
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
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