Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer
K-Number: K214117 · 2023-09-27
ApplicantAbbott Diagnostics Technologies AS
Decision Date2023-09-27
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer is a medical device manufactured by Abbott Diagnostics Technologies AS. It received FDA 510(k) clearance on 2023-09-27 under approval number K214117. 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 Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer?
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Abbott Diagnostics Technologies AS. The 510(k) number is K214117.
When was Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer approved by the FDA?
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer received FDA 510(k) clearance on 2023-09-27, under approval number K214117.
What company makes Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer?
Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer is manufactured by Abbott Diagnostics Technologies AS.
What is the FDA product code for Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer?
The FDA product code for Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer is LCP.
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.