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FDA 510(k)

Nova Allegro HbA1c Assay, Nova Allegro Analyzer

K-Number: K221326 · 2024-11-22

ApplicantNova Biomedical Corporation
Decision Date2024-11-22
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Nova Allegro HbA1c Assay, Nova Allegro Analyzer is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2024-11-22 under approval number K221326. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova Allegro HbA1c Assay, Nova Allegro Analyzer?

Nova Allegro HbA1c Assay, Nova Allegro Analyzer is a medical device that received FDA 510(k) clearance on 2024-11-22. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K221326.

When was Nova Allegro HbA1c Assay, Nova Allegro Analyzer approved by the FDA?

Nova Allegro HbA1c Assay, Nova Allegro Analyzer received FDA 510(k) clearance on 2024-11-22, under approval number K221326.

What company makes Nova Allegro HbA1c Assay, Nova Allegro Analyzer?

Nova Allegro HbA1c Assay, Nova Allegro Analyzer is manufactured by Nova Biomedical Corporation.

What is the FDA product code for Nova Allegro HbA1c Assay, Nova Allegro Analyzer?

The FDA product code for Nova Allegro HbA1c Assay, Nova Allegro Analyzer is LCP.

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Related Devices (Code: LCP)

K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDiazyme Laboratories K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics K170147Lucica Glycated Albumin-LAsahi Kasei Pharma Corporation K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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