FDA 510(k)

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

Numéro K : K232597 · 2024-01-09

DemandeurHangzhou Laihe Biotech Co., Ltd.

Date de décision2024-01-09

Code produitDJG

Comité consultatifTX

DécisionSubstantially Equivalent

Résumé du dispositif

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Laihe Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-01-09 under 510(k) number K232597. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)?

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) is a medical device that received FDA 510(k) clearance on 2024-01-09. The listed applicant is Hangzhou Laihe Biotech Co., Ltd.. The 510(k) number is K232597.

When did LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) receive FDA 510(k) clearance?

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) received FDA 510(k) clearance on 2024-01-09, under 510(k) number K232597.

Who is the listed applicant for LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)?

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

What is the FDA product code for LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)?

The FDA product code for LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) is DJG.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Hangzhou Laihe Biotech Co., Ltd. en tant que demandeur

K240287LYHER® Oral fluid Multi-Drug Test Kit (Cube)K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

Dispositifs connexes (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.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.