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FDA 510(k)

ONTRAK TESTCUP II AND ONSITE CUPKIT

K-Number: K033902 · 2004-01-20

ApplicantVarian, Inc.
Decision Date2004-01-20
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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 2004-01-20 under 510(k) number K033902. 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 II AND ONSITE CUPKIT?

ONTRAK TESTCUP II AND ONSITE CUPKIT is a medical device that received FDA 510(k) clearance on 2004-01-20. The listed applicant is Varian, Inc.. The 510(k) number is K033902.

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

ONTRAK TESTCUP II AND ONSITE CUPKIT received FDA 510(k) clearance on 2004-01-20, under 510(k) number K033902.

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

The FDA product code for ONTRAK TESTCUP II AND ONSITE CUPKIT is DKZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Varian, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060896MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKITK051235ON TRAK TESTCARDK050321ONTRAK TESTCARD 9K033659VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK

Related Devices (Code: DKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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.

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