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FDA 510(k)

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

K-Number: K182654 · 2018-11-19

ApplicantSafecare Biotech (Hangzhou) Co., Ltd.
Decision Date2018-11-19
Product CodeNGG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is a medical device manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2018-11-19 under approval number K182654. The device is classified under product code NGG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is a medical device that received FDA 510(k) clearance on 2018-11-19. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K182654.

When was SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card approved by the FDA?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card received FDA 510(k) clearance on 2018-11-19, under approval number K182654.

What company makes SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is manufactured by Safecare Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card?

The FDA product code for SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card is NGG.

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Other Devices by Safecare Biotech (Hangzhou) Co., Ltd.

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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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