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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Sm Antibody, Antigen And Control
510(k) Number K123593
Device Name QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Applicant Contact GABRIELLA LAKOS
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131
Correspondent Contact GABRIELLA LAKOS
Regulation Number866.5100
Classification Product Code
LKP  
Subsequent Product Codes
JIT   JJX   LKO  
Date Received11/21/2012
Decision Date 04/17/2013
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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