Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

K-Number: K200363 · 2020-03-11

ApplicantQuidel Cardiovascular, Inc.
Decision Date2020-03-11
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Quidel Triage® TOX Drug Screen, 94600 is a medical device manufactured by Quidel Cardiovascular, Inc.. It received FDA 510(k) clearance on 2020-03-11 under approval number K200363. 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® TOX Drug Screen, 94600 is a medical device that received FDA 510(k) clearance on 2020-03-11. It is manufactured by Quidel Cardiovascular, Inc.. The 510(k) number is K200363.

When was Quidel Triage® TOX Drug Screen, 94600 approved by the FDA?

Quidel Triage® TOX Drug Screen, 94600 received FDA 510(k) clearance on 2020-03-11, under approval number K200363.

What company makes Quidel Triage® TOX Drug Screen, 94600?

Quidel Triage® TOX Drug Screen, 94600 is manufactured by Quidel Cardiovascular, Inc..

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

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

Other Devices by Quidel Cardiovascular, Inc.

K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro

Related Devices (Code: DKZ)

K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsHangzhou Clongene Biotech Co., Ltd. K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)Alfa Scientific Designs, Inc. K152908UCP COMPACT DRUG TESTSUcp Biosciences, Inc. K152590ACCU NEWS Drug Screening Test Card/Urine CupCoretests, Inc. K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)Assure Tech. (Hangzhou) Co, Ltd. K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx UseShanghai Venture Bio-Tech 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.

↑