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FDA 510(k)

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11

K-Number: K220046 · 2022-12-13

ApplicantShenzhen Superbio Technology Co., Ltd.
Decision Date2022-12-13
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is a medical device manufactured by Shenzhen Superbio Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-13 under approval number K220046. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is a medical device that received FDA 510(k) clearance on 2022-12-13. It is manufactured by Shenzhen Superbio Technology Co., Ltd.. The 510(k) number is K220046.

When was Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 approved by the FDA?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 received FDA 510(k) clearance on 2022-12-13, under approval number K220046.

What company makes Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is manufactured by Shenzhen Superbio Technology Co., Ltd..

What is the FDA product code for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

The FDA product code for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is DJG.

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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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