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FDA 510(k)

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

K-Number: K153050 · 2016-04-26

ApplicantCo-Innovation Biotech Co., Ltd.
Decision Date2016-04-26
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is a medical device manufactured by Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2016-04-26 under approval number K153050. 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 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is a medical device that received FDA 510(k) clearance on 2016-04-26. It is manufactured by Co-Innovation Biotech Co., Ltd.. The 510(k) number is K153050.

When was Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard approved by the FDA?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard received FDA 510(k) clearance on 2016-04-26, under approval number K153050.

What company makes Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is manufactured by Co-Innovation Biotech Co., Ltd..

What is the FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard?

The FDA product code for Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard is DJG.

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Related PubMed Literature

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Other Devices by Co-Innovation Biotech Co., Ltd.

K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

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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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