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FDA 510(k)

HbA1c Advanced

K-Number: K182651 · 2019-01-16

ApplicantBeckman Coulter Ireland, Inc.
Decision Date2019-01-16
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HbA1c Advanced is a medical device manufactured by Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2019-01-16 under approval number K182651. 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 HbA1c Advanced?

HbA1c Advanced is a medical device that received FDA 510(k) clearance on 2019-01-16. It is manufactured by Beckman Coulter Ireland, Inc.. The 510(k) number is K182651.

When was HbA1c Advanced approved by the FDA?

HbA1c Advanced received FDA 510(k) clearance on 2019-01-16, under approval number K182651.

What company makes HbA1c Advanced?

HbA1c Advanced is manufactured by Beckman Coulter Ireland, Inc..

What is the FDA product code for HbA1c Advanced?

The FDA product code for HbA1c Advanced is PDJ.

Other Devices by Beckman Coulter Ireland, Inc.

K161297Beta-2-Microglobulin K161508Ceruloplasmin

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.

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