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FDA 510(k)

ONTRAK TESTCUP-ER M2K

K-Number: K990418 · 1999-04-13

ApplicantRoche Diagnostics Corp.
Decision Date1999-04-13
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTCUP-ER 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 1999-04-13 under 510(k) number K990418. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONTRAK TESTCUP-ER M2K?

ONTRAK TESTCUP-ER M2K is a medical device that received FDA 510(k) clearance on 1999-04-13. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K990418.

When did ONTRAK TESTCUP-ER M2K receive FDA 510(k) clearance?

ONTRAK TESTCUP-ER M2K received FDA 510(k) clearance on 1999-04-13, under 510(k) number K990418.

Who is the listed applicant for ONTRAK TESTCUP-ER 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 TESTCUP-ER M2K?

The FDA product code for ONTRAK TESTCUP-ER M2K is DKZ.

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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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