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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 the device name listed in this FDA 510(k) record. The listed applicant is Co-Innovation Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) 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. The listed applicant is Co-Innovation Biotech Co., Ltd.. The 510(k) number is K231904.

When did Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard receive FDA 510(k) clearance?

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

Who is the listed applicant for Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard?

The FDA 510(k) record lists Co-Innovation Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Co-Innovation Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardK232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50K213808Co-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 MidstreamK153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

Related Devices (Code: DJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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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