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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Ireland, Inc.. It received FDA 510(k) clearance on 2019-01-16 under 510(k) 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. The listed applicant is Beckman Coulter Ireland, Inc.. The 510(k) number is K182651.

When did HbA1c Advanced receive FDA 510(k) clearance?

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

Who is the listed applicant for HbA1c Advanced?

The FDA 510(k) record lists Beckman Coulter Ireland, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HbA1c Advanced?

The FDA product code for HbA1c Advanced is PDJ.

Other records listing Beckman Coulter Ireland, Inc. 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.

K161508CeruloplasminK161297Beta-2-Microglobulin

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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