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 a medical device manufactured by Alere Technologies AS. It received FDA 510(k) clearance on 2018-11-29 under approval 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. It is manufactured by Alere Technologies AS. The 510(k) number is K182988.
When was Afinion HbA1c Dx on Afinion 2 approved by the FDA?
Afinion HbA1c Dx on Afinion 2 received FDA 510(k) clearance on 2018-11-29, under approval number K182988.
What company makes Afinion HbA1c Dx on Afinion 2?
Afinion HbA1c Dx on Afinion 2 is manufactured by Alere Technologies AS.
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.
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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.