Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K181968 · 2018-08-20

Decision Date2018-08-20
Product CodeNFT
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 2018-08-20 under approval number K181968. The device is classified under product code NFT. 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 2018-08-20. It is manufactured by Safecare Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K181968.

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 2018-08-20, under approval number K181968.

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 NFT.

Related Clinical Trials

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

View all 9 devices →

Related Devices (Code: NFT)

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.