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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K922351
Device Name QUANTA LITE(TM) IGA ACA
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
MID  
Date Received05/19/1992
Decision Date 09/29/1992
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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