AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests— 510(k) K201630

Substantially Equivalent

Assure Tech. (Hangzhou) Co, Ltd.

FDA 510(k) clearance K201630 for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests, Substantially Equivalent on 2021-08-12. Applicant: Assure Tech. (Hangzhou) Co, Ltd..

Clearance details

Applicant: Assure Tech. (Hangzhou) Co, Ltd.
Product code: Code DJG
Advisory panel: Clinical Toxicology
Date received: 2020-06-16
Decision date: 2021-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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