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FDA 510(k)

ROCHE FLUDI METHAMPHETAMINE

K-Number: K093884 · 2011-02-25

ApplicantRoche Diagnostics
Decision Date2011-02-25
Product CodeLAF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ROCHE FLUDI METHAMPHETAMINE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2011-02-25 under 510(k) number K093884. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE FLUDI METHAMPHETAMINE?

ROCHE FLUDI METHAMPHETAMINE is a medical device that received FDA 510(k) clearance on 2011-02-25. The listed applicant is Roche Diagnostics. The 510(k) number is K093884.

When did ROCHE FLUDI METHAMPHETAMINE receive FDA 510(k) clearance?

ROCHE FLUDI METHAMPHETAMINE received FDA 510(k) clearance on 2011-02-25, under 510(k) number K093884.

Who is the listed applicant for ROCHE FLUDI METHAMPHETAMINE?

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

What is the FDA product code for ROCHE FLUDI METHAMPHETAMINE?

The FDA product code for ROCHE FLUDI METHAMPHETAMINE is LAF.

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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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