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FDA 510(k)

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests

K-Number: K153192 · 2016-04-18

ApplicantChemtron Biotech, Inc.
Decision Date2016-04-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests is a medical device manufactured by Chemtron Biotech, Inc.. It received FDA 510(k) clearance on 2016-04-18 under approval number K153192. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests?

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests is a medical device that received FDA 510(k) clearance on 2016-04-18. It is manufactured by Chemtron Biotech, Inc.. The 510(k) number is K153192.

When was Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests approved by the FDA?

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests received FDA 510(k) clearance on 2016-04-18, under approval number K153192.

What company makes Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests?

Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests is manufactured by Chemtron Biotech, Inc..

What is the FDA product code for Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests?

The FDA product code for Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests is DJG.

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Related PubMed Literature

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Other Devices by Chemtron Biotech, Inc.

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

Related Devices (Code: DJG)

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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.

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