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FDA 510(k)

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

K-Number: K060001 · 2006-01-20

ApplicantBio-Rad Laboratories, Inc.
Decision Date2006-01-20
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL 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 2006-01-20 under 510(k) number K060001. 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 D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM?

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM is a medical device that received FDA 510(k) clearance on 2006-01-20. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K060001.

When did D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM receive FDA 510(k) clearance?

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM received FDA 510(k) clearance on 2006-01-20, under 510(k) number K060001.

Who is the listed applicant for D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL 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; D-10 DUAL PROGRAM?

The FDA product code for D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM is LCP.

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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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