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FDA 510(k)

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS

K-Number: K123080 · 2012-11-29

ApplicantChemtron Biotech, Inc.
Decision Date2012-11-29
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE 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 2012-11-29 under 510(k) number K123080. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS?

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS is a medical device that received FDA 510(k) clearance on 2012-11-29. The listed applicant is Chemtron Biotech, Inc.. The 510(k) number is K123080.

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

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS received FDA 510(k) clearance on 2012-11-29, under 510(k) number K123080.

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

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

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Other records listing Chemtron Biotech, 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.

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 TestK153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsK131931CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TESTK123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TESTK121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTSK111322CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD

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Related Devices (Code: JXM)

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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.

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