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FDA 510(k)

ORTHO T. CRUZI ELISA TEST SYSTEM

K-Number: K072732 · 2009-04-15

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2009-04-15
Product CodeMIU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO T. CRUZI ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2009-04-15 under 510(k) number K072732. The device is classified under product code MIU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO T. CRUZI ELISA TEST SYSTEM?

ORTHO T. CRUZI ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K072732.

When did ORTHO T. CRUZI ELISA TEST SYSTEM receive FDA 510(k) clearance?

ORTHO T. CRUZI ELISA TEST SYSTEM received FDA 510(k) clearance on 2009-04-15, under 510(k) number K072732.

Who is the listed applicant for ORTHO T. CRUZI ELISA TEST SYSTEM?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO T. CRUZI ELISA TEST SYSTEM?

The FDA product code for ORTHO T. CRUZI ELISA TEST SYSTEM is MIU.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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