FDA 510(k)

CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS

K-Number: K102203 · 2011-01-20

Decision Date2011-01-20

Product CodeDKZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS is the device name listed in this FDA 510(k) record. The listed applicant is Chemtron Biotech, Inc.. It received FDA 510(k) clearance on 2011-01-20 under 510(k) number K102203. 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 CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS?

CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Chemtron Biotech, Inc.. The 510(k) number is K102203.

When did CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS receive FDA 510(k) clearance?

CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS received FDA 510(k) clearance on 2011-01-20, under 510(k) number K102203.

Who is the listed applicant for CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS?

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

What is the FDA product code for CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS?

The FDA product code for CHEMTRUE SINGLE / MULTI DRUG SCREEN CASSETTE / DIP CARD TESTS is DKZ.

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Other records listing Chemtron Biotech, Inc. as applicant

K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests K131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST K123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS K121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS

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Related Devices (Code: DKZ)

K240670DRI Ecstasy Plus AssayMicrogenics Corporation K233019AllTest 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 Medical K182719Quidel 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.