FDA 510(k)

ONTRAK TESTCUP PRO-5, MODEL 1986678

K-Number: K001356 · 2000-07-10

Decision Date2000-07-10

Product CodeDJC

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ONTRAK TESTCUP PRO-5, MODEL 1986678 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 2000-07-10 under 510(k) number K001356. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONTRAK TESTCUP PRO-5, MODEL 1986678?

ONTRAK TESTCUP PRO-5, MODEL 1986678 is a medical device that received FDA 510(k) clearance on 2000-07-10. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K001356.

When did ONTRAK TESTCUP PRO-5, MODEL 1986678 receive FDA 510(k) clearance?

ONTRAK TESTCUP PRO-5, MODEL 1986678 received FDA 510(k) clearance on 2000-07-10, under 510(k) number K001356.

Who is the listed applicant for ONTRAK TESTCUP PRO-5, MODEL 1986678?

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 PRO-5, MODEL 1986678?

The FDA product code for ONTRAK TESTCUP PRO-5, MODEL 1986678 is DJC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.