Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000— 510(k) K143599

Substantially Equivalent

Chemtron Biotech, Inc.

FDA 510(k) clearance K143599 for Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000, Substantially Equivalent on 2015-04-17. Applicant: Chemtron Biotech, Inc..

Clearance details

Applicant: Chemtron Biotech, Inc.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2014-12-18
Decision date: 2015-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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