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FDA 510(k)

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)

K-Number: K990409 · 1999-04-15

ApplicantRoche Diagnostics Corp.
Decision Date1999-04-15
Product CodeDMY
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 1999-04-15 under 510(k) number K990409. The device is classified under product code DMY. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)?

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) is a medical device that received FDA 510(k) clearance on 1999-04-15. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K990409.

When did ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) receive FDA 510(k) clearance?

ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) received FDA 510(k) clearance on 1999-04-15, under 510(k) number K990409.

Who is the listed applicant for ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)?

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

What is the FDA product code for ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)?

The FDA product code for ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) is DMY.

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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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