FDA 510(k)

VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS

K-Number: K062165 · 2007-01-05

Decision Date2007-01-05

Product CodeDIS

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS 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 2007-01-05 under 510(k) number K062165. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS?

VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS is a medical device that received FDA 510(k) clearance on 2007-01-05. The listed applicant is Ortho-Clinical Diagnostics. The 510(k) number is K062165.

When did VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS receive FDA 510(k) clearance?

VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS received FDA 510(k) clearance on 2007-01-05, under 510(k) number K062165.

Who is the listed applicant for VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS?

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 VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS?

The FDA product code for VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS is DIS.

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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.