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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lambda, Antigen, Antiserum, Control
510(k) Number K950151
Device Name CHEMMATE(TM) L26 (CD20)
Applicant
Biotek Solutions, Inc.
120-B Cremona Dr.
Santa Barbara,  CA  93117
Applicant Contact DEBORAH D HINMAN
Correspondent
Biotek Solutions, Inc.
120-B Cremona Dr.
Santa Barbara,  CA  93117
Correspondent Contact DEBORAH D HINMAN
Regulation Number866.5550
Classification Product Code
DEH  
Subsequent Product Code
LAM  
Date Received01/17/1995
Decision Date 10/04/1995
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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