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FDA 510(k)

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD

K-Number: K111322 · 2011-09-14

ApplicantChemtron Biotech, Inc.
Decision Date2011-09-14
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD 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 2011-09-14 under 510(k) number K111322. 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 CASSETTE/DIPCARD?

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD is a medical device that received FDA 510(k) clearance on 2011-09-14. The listed applicant is Chemtron Biotech, Inc.. The 510(k) number is K111322.

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

CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD received FDA 510(k) clearance on 2011-09-14, under 510(k) number K111322.

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

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 CASSETTE/DIPCARD?

The FDA product code for CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD 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 TESTK123080CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTSK121339CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS

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Related Devices (Code: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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