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FDA 510(k)

ONTRAK TESTCUP 501, MODEL 3016633

K-Number: K001421 · 2000-07-12

ApplicantRoche Diagnostics Corp.
Decision Date2000-07-12
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTCUP 501, MODEL 3016633 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 2000-07-12 under 510(k) number K001421. 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 501, MODEL 3016633?

ONTRAK TESTCUP 501, MODEL 3016633 is a medical device that received FDA 510(k) clearance on 2000-07-12. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K001421.

When did ONTRAK TESTCUP 501, MODEL 3016633 receive FDA 510(k) clearance?

ONTRAK TESTCUP 501, MODEL 3016633 received FDA 510(k) clearance on 2000-07-12, under 510(k) number K001421.

Who is the listed applicant for ONTRAK TESTCUP 501, MODEL 3016633?

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 501, MODEL 3016633?

The FDA product code for ONTRAK TESTCUP 501, MODEL 3016633 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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