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FDA 510(k)

Aina HbA1c Monitoring System 2

K-Number: K192987 · 2020-03-26

ApplicantJana Care, Inc.
Decision Date2020-03-26
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Aina HbA1c Monitoring System 2 is the device name listed in this FDA 510(k) record. The listed applicant is Jana Care, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192987. 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 Aina HbA1c Monitoring System 2?

Aina HbA1c Monitoring System 2 is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Jana Care, Inc.. The 510(k) number is K192987.

When did Aina HbA1c Monitoring System 2 receive FDA 510(k) clearance?

Aina HbA1c Monitoring System 2 received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192987.

Who is the listed applicant for Aina HbA1c Monitoring System 2?

The FDA 510(k) record lists Jana Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aina HbA1c Monitoring System 2?

The FDA product code for Aina HbA1c Monitoring System 2 is LCP.

Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.

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.

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