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FDA 510(k)

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

K-Number: K240654 · 2024-04-10

ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Decision Date2024-04-10
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is a medical device manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-04-10 under approval number K240654. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is a medical device that received FDA 510(k) clearance on 2024-04-10. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K240654.

When was SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette approved by the FDA?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette received FDA 510(k) clearance on 2024-04-10, under approval number K240654.

What company makes SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is manufactured by Safecare Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette?

The FDA product code for SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette is NGL.

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Related Devices (Code: NGL)

K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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