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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
510(k) Number K936251
Device Name COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
Applicant
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact PRISCILLA ZIA, PH.D.
Correspondent
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact PRISCILLA ZIA, PH.D.
Regulation Number866.3145
Classification Product Code
GNM  
Date Received12/30/1993
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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