AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201630

Identifiers

510(k) Number: K201630 FDA 510(k)
FDA Product Code: DJG FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3650 FDA 510(k)
Regulation Number: 862.3650 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests by Assure Tech. (hangzhou) Co., Ltd. — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K201630	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Assure Tech. (hangzhou) Co., Ltd.
FDA Applicant: Assure Tech. (Hangzhou) Co, Ltd.

Sources (1)

FDA 510(k) K201630 24 fields · synced Jun 18, 2026