FDA 510(k)

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

K-Nummer: K231904 · 2024-03-08

AntragstellerCo-Innovation Biotech Co., Ltd.

Entscheidungsdatum2024-03-08

ProduktcodeDJG

BeratungsausschussTX

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Co-Innovation Biotech Co., Ltd. als Antragsteller

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Verwandte Geräte (Code: DJG)

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLC K251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

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