FDA 510(k)

Kit de Reagente Total ß-hCG Alinity i, Sistemas GLP Track

Número K: K230937 · 2023-06-05

Data da decisão2023-06-05

Código do produtoDHA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230937. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Abbott Laboratories. The 510(k) number is K230937.

When did Alinity i Total ß-hCG Reagent Kit, GLP systems Track receive FDA 510(k) clearance?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230937.

Who is the listed applicant for Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

The FDA product code for Alinity i Total ß-hCG Reagent Kit, GLP systems Track is DHA.

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Outros registros que listam Abbott Laboratories como candidato(a)

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Dispositivos Relacionados (Código: DHA)

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical Diagnostics K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230790Kit de Reagente Total B-hCG Alinity i, Kit de Reagente de Glicose Alinity c, Disolvente de Amostra ICT Alinity c, Série Alinity ciAbbott Laboratories K221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc.K203227Elecsys HCG STATRoche Diagnostics

Fonte oficial

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