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FDA 510(k)

VITROS CHEMISTRY PRODUCTS DHDL SLIDES

K-Number: K120609 · 2012-09-07

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2012-09-07
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS DHDL SLIDES 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 2012-09-07 under 510(k) number K120609. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS DHDL SLIDES?

VITROS CHEMISTRY PRODUCTS DHDL SLIDES is a medical device that received FDA 510(k) clearance on 2012-09-07. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K120609.

When did VITROS CHEMISTRY PRODUCTS DHDL SLIDES receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS DHDL SLIDES received FDA 510(k) clearance on 2012-09-07, under 510(k) number K120609.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS DHDL SLIDES?

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 DHDL SLIDES?

The FDA product code for VITROS CHEMISTRY PRODUCTS DHDL SLIDES is LBS.

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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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