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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 a medical device manufactured by Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2021-08-12 under approval 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. It is manufactured by Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K201630.

When was AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests approved by the FDA?

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

What company makes AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests?

AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests is manufactured by Assure Tech. (Hangzhou) Co, Ltd..

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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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Assure Tech. (Hangzhou) Co, Ltd.

K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) K170049AssureTech Panel Dip Test, AssureTech Quick Cup Test K181768AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K180349AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream

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Related Devices (Code: 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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