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FDA 510(k)

D-10 Hemoglobin A1c Program

K-Number: K161687 · 2016-10-14

ApplicantBio-Rad Laboratories, Inc.
Decision Date2016-10-14
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

D-10 Hemoglobin A1c Program is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161687. 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 D-10 Hemoglobin A1c Program?

D-10 Hemoglobin A1c Program is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K161687.

When did D-10 Hemoglobin A1c Program receive FDA 510(k) clearance?

D-10 Hemoglobin A1c Program received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161687.

Who is the listed applicant for D-10 Hemoglobin A1c Program?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for D-10 Hemoglobin A1c Program?

The FDA product code for D-10 Hemoglobin A1c Program 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.

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