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FDA 510(k)

ONTRAK TESTCUP 502, MODEL 3016641

K-Number: K001417 · 2000-06-29

ApplicantRoche Diagnostics Corp.
Decision Date2000-06-29
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTCUP 502, MODEL 3016641 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 2000-06-29 under 510(k) number K001417. 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 502, MODEL 3016641?

ONTRAK TESTCUP 502, MODEL 3016641 is a medical device that received FDA 510(k) clearance on 2000-06-29. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K001417.

When did ONTRAK TESTCUP 502, MODEL 3016641 receive FDA 510(k) clearance?

ONTRAK TESTCUP 502, MODEL 3016641 received FDA 510(k) clearance on 2000-06-29, under 510(k) number K001417.

Who is the listed applicant for ONTRAK TESTCUP 502, MODEL 3016641?

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 502, MODEL 3016641?

The FDA product code for ONTRAK TESTCUP 502, MODEL 3016641 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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