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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K961340
Device Name NOVA LITE ANCA
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 Number866.5660
Classification Product Code
MOB  
Date Received03/25/1996
Decision Date 07/10/1996
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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