EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine T…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152643

Identifiers

510(k) Number: K152643 FDA 510(k)
FDA Product Code: LDJ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 862.3870 FDA 510(k)
Regulation Number: 862.3870 FDA 510(k)
Advisory Committee: Clinical Toxicology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine T… by Nantong Egens Biotech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)

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	K152643	Class II	Active

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Manufacturer

Manufacturer: Nantong Egens Biotech Co., Ltd.

Sources (1)

FDA 510(k) K152643 24 fields · synced Jun 18, 2026