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SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202453

by Safecare Biotech (Hangzhou) Co., Ltd.

Identifiers

510(k) Number
K202453 FDA 510(k)
FDA Product Code
NFT 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)

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card by Safecare Biotech (Hangzhou) Co., Ltd. — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Sources (1)

  • FDA 510(k) K202453 24 fields · synced Jun 19, 2026