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)

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard

K-Number: K231904 · 2024-03-08

ApplicantCo-Innovation Biotech Co., Ltd.
Decision Date2024-03-08
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard is a medical device manufactured by Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-08 under approval number K231904. 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 Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard?

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Co-Innovation Biotech Co., Ltd.. The 510(k) number is K231904.

When was Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard approved by the FDA?

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard received FDA 510(k) clearance on 2024-03-08, under approval number K231904.

What company makes Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard?

Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard is manufactured by Co-Innovation Biotech Co., Ltd..

What is the FDA product code for Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard?

The FDA product code for Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard is DJG.

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

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard 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 K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

Related Devices (Code: DJG)

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsChemtron Biotech, Inc. K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics Corporation

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.

↑