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FDA 510(k)

THE VITROS 5,1 FS CHEMISTRY SYSTEM

K-Number: K041764 · 2004-09-09

ApplicantOrtho-Clinical Diagnostics
Decision Date2004-09-09
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THE VITROS 5,1 FS CHEMISTRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics. It received FDA 510(k) clearance on 2004-09-09 under 510(k) number K041764. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE VITROS 5,1 FS CHEMISTRY SYSTEM?

THE VITROS 5,1 FS CHEMISTRY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-09-09. The listed applicant is Ortho-Clinical Diagnostics. The 510(k) number is K041764.

When did THE VITROS 5,1 FS CHEMISTRY SYSTEM receive FDA 510(k) clearance?

THE VITROS 5,1 FS CHEMISTRY SYSTEM received FDA 510(k) clearance on 2004-09-09, under 510(k) number K041764.

Who is the listed applicant for THE VITROS 5,1 FS CHEMISTRY SYSTEM?

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

What is the FDA product code for THE VITROS 5,1 FS CHEMISTRY SYSTEM?

The FDA product code for THE VITROS 5,1 FS CHEMISTRY SYSTEM is LCP.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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