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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Influenza Virus A, B, C
510(k) Number K974302
Device Name LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B
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 Number866.3330
Classification Product Code
GNW  
Date Received11/17/1997
Decision Date 04/08/1998
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
Recalls CDRH Recalls
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