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

FDA 510(k)

Afinion HbA1c Dx

K-Number: K180296 · 2018-05-07

ApplicantAlere Technologies AS
Decision Date2018-05-07
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Afinion HbA1c Dx is a medical device manufactured by Alere Technologies AS. It received FDA 510(k) clearance on 2018-05-07 under approval number K180296. 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?

Afinion HbA1c Dx is a medical device that received FDA 510(k) clearance on 2018-05-07. It is manufactured by Alere Technologies AS. The 510(k) number is K180296.

When was Afinion HbA1c Dx approved by the FDA?

Afinion HbA1c Dx received FDA 510(k) clearance on 2018-05-07, under approval number K180296.

What company makes Afinion HbA1c Dx?

Afinion HbA1c Dx is manufactured by Alere Technologies AS.

What is the FDA product code for Afinion HbA1c Dx?

The FDA product code for Afinion HbA1c Dx is PDJ.

Other Devices by Alere Technologies AS

K182988Afinion HbA1c Dx on Afinion 2

Related Devices (Code: PDJ)

K160571cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 AssayRoche Diagnostics Operations (Rdo) K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc. K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. K171537CAPI 3 Hb A1cSebia K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc. K182988Afinion HbA1c Dx on Afinion 2Alere Technologies AS

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.

↑