FDA 510(k)

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT

K-Number: K060896 · 2006-06-09

Decision Date2006-06-09

Product CodeDJC

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT is the device name listed in this FDA 510(k) record. The listed applicant is Varian, Inc.. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K060896. 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 MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT?

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Varian, Inc.. The 510(k) number is K060896.

When did MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT receive FDA 510(k) clearance?

MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT received FDA 510(k) clearance on 2006-06-09, under 510(k) number K060896.

Who is the listed applicant for MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT?

The FDA 510(k) record lists Varian, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT?

The FDA product code for MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT is DJC.

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Other records listing Varian, Inc. as applicant

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Related Devices (Code: DJC)

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.