FDA 510(k)

Kit de réactif Alinity i Total B-hCG, Kit de réactif Alinity c Glucose, Diluant de prélèvement Alinity c ICT, Série Alinity ci

Numéro K : K230790 · 2023-05-19

Date de décision2023-05-19

Code produitDHA

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-05-19 under 510(k) number K230790. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is a medical device that received FDA 510(k) clearance on 2023-05-19. The listed applicant is Abbott Laboratories. The 510(k) number is K230790.

When did Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series receive FDA 510(k) clearance?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series received FDA 510(k) clearance on 2023-05-19, under 510(k) number K230790.

Who is the listed applicant for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

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 B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

The FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is DHA.

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Dispositifs connexes (Code : 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.K230937Kit de réactif Alinity i Total ß-hCG, Systèmes GLP TrackAbbott 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

Source officielle

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