FDA 510(k)

DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS

K-Number: K081378 · 2009-01-14

Decision Date2009-01-14

Product CodeDJR

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2009-01-14 under 510(k) number K081378. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS?

DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS is a medical device that received FDA 510(k) clearance on 2009-01-14. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K081378.

When did DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS receive FDA 510(k) clearance?

DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS received FDA 510(k) clearance on 2009-01-14, under 510(k) number K081378.

Who is the listed applicant for DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS?

The FDA product code for DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS is DJR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.