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FDA 510(k)

VARIANT II HEMOGLOBIN A1C

K-Number: K040872 · 2004-04-15

ApplicantBio-Rad Laboratories, Inc.
Decision Date2004-04-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT II HEMOGLOBIN A1C 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 2004-04-15 under 510(k) number K040872. 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 VARIANT II HEMOGLOBIN A1C?

VARIANT II HEMOGLOBIN A1C is a medical device that received FDA 510(k) clearance on 2004-04-15. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K040872.

When did VARIANT II HEMOGLOBIN A1C receive FDA 510(k) clearance?

VARIANT II HEMOGLOBIN A1C received FDA 510(k) clearance on 2004-04-15, under 510(k) number K040872.

Who is the listed applicant for VARIANT II HEMOGLOBIN A1C?

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 VARIANT II HEMOGLOBIN A1C?

The FDA product code for VARIANT II HEMOGLOBIN A1C is LCP.

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Related Devices (Code: 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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