AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K153465

Identifiers

510(k) Number: K153465 FDA 510(k)
FDA Product Code: DKZ FDA 510(k)
Models / Variants: Strip FDA 510(k)
Dip Card FDA 510(k)
Quick Cup FDA 510(k)
Turn-Key Split Cup FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3100 FDA 510(k)
Regulation Number: 862.3100 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), … 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	K153465	Class II	Active

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Manufacturer

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

Sources (1)

FDA 510(k) K153465 24 fields · synced Jun 18, 2026