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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Outer-Membrane Proteins
510(k) Number K081248
Device Name QUANTA LITE OMP PLUS ELISA
Applicant
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Applicant Contact ZAKERA SHUMS
Correspondent
Inova Diagnostics, Inc.
9900 Old Grove Rd.
San Diego,  CA  92131 -1638
Correspondent Contact ZAKERA SHUMS
Regulation Number866.5785
Classification Product Code
OKM  
Date Received05/02/2008
Decision Date 10/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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