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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Cf, (Including Cf Control), Varicella-Zoster
510(k) Number K990141
Device Name LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295
Applicant
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Applicant Contact CINDY PENNY
Correspondent
Light Diagnostics
28835 Single Oak Dr.
Temecula,  CA  92590
Correspondent Contact CINDY PENNY
Regulation Number866.3900
Classification Product Code
GQW  
Date Received01/19/1999
Decision Date 10/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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