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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunosorbent Assay, T. Cruzi
510(k) Number K072732
Device Name ORTHO T. CRUZI ELISA TEST SYSTEM
Applicant
Ortho-Clinical Diagnostics, Inc.
1001 U.S. Hwy. 202
Raritan,  NJ  08869 -0606
Applicant Contact ANDREA J CASPER
Correspondent
Ortho-Clinical Diagnostics, Inc.
1001 U.S. Hwy. 202
Raritan,  NJ  08869 -0606
Correspondent Contact ANDREA J CASPER
Regulation Number866.3870
Classification Product Code
MIU  
Date Received09/26/2007
Decision Date 04/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
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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