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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 K946385
Device Name QUANTA LITE ACA IGM (HRP)
Applicant
Inova Diagnostics, Inc.
10451 Roselle St.
San Diego,  CA  92121
Applicant Contact BYRS C MYERS
Correspondent
Inova Diagnostics, Inc.
10451 Roselle St.
San Diego,  CA  92121
Correspondent Contact BYRS C MYERS
Regulation Number866.5660
Classification Product Code
MID  
Date Received12/09/1994
Decision Date 07/18/1995
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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