Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Afinion HbA1c Dx on Afinion 2

K-Number: K182988 · 2018-11-29

ApplicantAlere Technologies AS
Decision Date2018-11-29
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Afinion HbA1c Dx on Afinion 2 is the device name listed in this FDA 510(k) record. The listed applicant is Alere Technologies AS. It received FDA 510(k) clearance on 2018-11-29 under 510(k) number K182988. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Afinion HbA1c Dx on Afinion 2?

Afinion HbA1c Dx on Afinion 2 is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Alere Technologies AS. The 510(k) number is K182988.

When did Afinion HbA1c Dx on Afinion 2 receive FDA 510(k) clearance?

Afinion HbA1c Dx on Afinion 2 received FDA 510(k) clearance on 2018-11-29, under 510(k) number K182988.

Who is the listed applicant for Afinion HbA1c Dx on Afinion 2?

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

What is the FDA product code for Afinion HbA1c Dx on Afinion 2?

The FDA product code for Afinion HbA1c Dx on Afinion 2 is PDJ.

Other records listing Alere Technologies AS as applicant

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.

K180296Afinion HbA1c Dx

Related Devices (Code: PDJ)

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.

K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.

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.

↑