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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 K120817
Device Name QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact ROSANNA KEIVENS
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact ROSANNA KEIVENS
Regulation Number866.5660
Classification Product Code
MID  
Subsequent Product Codes
JJX   MSV  
Date Received03/19/2012
Decision Date 02/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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