Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

K-Number: K182719 · 2019-06-19

ApplicantQuidel Cardiovascular, Inc.
Decision Date2019-06-19
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Cardiovascular, Inc.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K182719. 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 Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Quidel Cardiovascular, Inc.. The 510(k) number is K182719.

When did Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro receive FDA 510(k) clearance?

Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro received FDA 510(k) clearance on 2019-06-19, under 510(k) number K182719.

Who is the listed applicant for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

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

What is the FDA product code for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro?

The FDA product code for Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro is DKZ.

Other records listing Quidel Cardiovascular, 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.

K200363Quidel Triage® TOX Drug Screen, 94600

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 MedicalK182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.

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.

↑