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FDA 510(k)

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests

K-Number: K201630 · 2021-08-12

ApplicantAssure Tech. (Hangzhou) Co, Ltd.
Decision Date2021-08-12
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2021-08-12 under 510(k) number K201630. 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 AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests?

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests is a medical device that received FDA 510(k) clearance on 2021-08-12. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K201630.

When did AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests receive FDA 510(k) clearance?

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests received FDA 510(k) clearance on 2021-08-12, under 510(k) number K201630.

Who is the listed applicant for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests?

The FDA 510(k) record lists Assure Tech. (Hangzhou) Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests?

The FDA product code for AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests is DJG.

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Official Source

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

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