ORTHO T. CRUZI ELISA TEST SYSTEM— 510(k) K072732

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K072732 for ORTHO T. CRUZI ELISA TEST SYSTEM, Substantially Equivalent on 2009-04-15. Applicant: Ortho-Clinical Diagnostics, Inc..

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code MIU
Advisory panel: Microbiology
Date received: 2007-09-26
Decision date: 2009-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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