FDA 510(k)

Alinity i Total ß-hCG Reagent Kit, Alinity i System

K-Number: K170317 · 2017-10-23

Decision Date2017-10-23

Product CodeDHA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Alinity i Total ß-hCG Reagent Kit, Alinity i System is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-23 under approval number K170317. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity i Total ß-hCG Reagent Kit, Alinity i System?

Alinity i Total ß-hCG Reagent Kit, Alinity i System is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Abbott Laboratories. The 510(k) number is K170317.

When was Alinity i Total ß-hCG Reagent Kit, Alinity i System approved by the FDA?

Alinity i Total ß-hCG Reagent Kit, Alinity i System received FDA 510(k) clearance on 2017-10-23, under approval number K170317.

What company makes Alinity i Total ß-hCG Reagent Kit, Alinity i System?

Alinity i Total ß-hCG Reagent Kit, Alinity i System is manufactured by Abbott Laboratories.

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

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

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Related PubMed Literature

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Other Devices by Abbott Laboratories

K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control K173122Abbott Architect Free T4 K170320Alinity c ICT Sample Diluent K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM K163342i-STAT Hematocrit test with i-STAT Alinity System

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Related Devices (Code: DHA)

K163418Diazyme DZ-Lite Total beta-hCG Test SystemDiazyme Laboratories K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K192547MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. K203227Elecsys HCG STATRoche Diagnostics K200210ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, 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.