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FDA 510(k)

VITROS CHEMISTRY PRODUCTS DTIBC REAGENT

K-Number: K052867 · 2005-12-23

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2005-12-23
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS DTIBC REAGENT 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 2005-12-23 under 510(k) number K052867. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS DTIBC REAGENT?

VITROS CHEMISTRY PRODUCTS DTIBC REAGENT is a medical device that received FDA 510(k) clearance on 2005-12-23. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K052867.

When did VITROS CHEMISTRY PRODUCTS DTIBC REAGENT receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS DTIBC REAGENT received FDA 510(k) clearance on 2005-12-23, under 510(k) number K052867.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS DTIBC REAGENT?

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 VITROS CHEMISTRY PRODUCTS DTIBC REAGENT?

The FDA product code for VITROS CHEMISTRY PRODUCTS DTIBC REAGENT is JMO.

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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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