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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K881340
Device Name NOVA LITE(TM) AUTOANTIBODY CONTROLS
Applicant
Inova Diagnostics, Inc.
10451 Roselle St.
San Diego,  CA  92121
Applicant Contact BRYS C MYERS
Correspondent
Inova Diagnostics, Inc.
10451 Roselle St.
San Diego,  CA  92121
Correspondent Contact BRYS C MYERS
Regulation Number866.5100
Classification Product Code
LLL  
Date Received03/29/1988
Decision Date 06/08/1988
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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