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FDA 510(k)

VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE

K-Number: K042006 · 2004-10-28

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2004-10-28
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE 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 2004-10-28 under 510(k) number K042006. 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 CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE?

VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE is a medical device that received FDA 510(k) clearance on 2004-10-28. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K042006.

When did VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE received FDA 510(k) clearance on 2004-10-28, under 510(k) number K042006.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE?

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, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE?

The FDA product code for VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE 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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