ORTHO T. CRUZI ELISA TEST SYSTEM

Enzyme Linked Immunosorbent Assay, T. Cruzi

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Ortho T. Cruzi Elisa Test System.

Pre-market Notification Details

Device IDK072732
510k NumberK072732
Device Name:ORTHO T. CRUZI ELISA TEST SYSTEM
ClassificationEnzyme Linked Immunosorbent Assay, T. Cruzi
Applicant Ortho-Clinical Diagnostics, Inc. 1001 U.S. HWY. 202 Raritan,  NJ  08869 -0606
ContactAndrea J Casper
CorrespondentAndrea J Casper
Ortho-Clinical Diagnostics, Inc. 1001 U.S. HWY. 202 Raritan,  NJ  08869 -0606
Product CodeMIU  
CFR Regulation Number866.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-26
Decision Date2009-04-15
Summary:summary

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