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FDA 510(k)

VARIANT II HEMOGLOBIN A1C PROGRAM

K-Number: K984268 · 1998-12-17

ApplicantBio-Rad
Decision Date1998-12-17
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT II HEMOGLOBIN A1C PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-12-17 under 510(k) number K984268. 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 PROGRAM?

VARIANT II HEMOGLOBIN A1C PROGRAM is a medical device that received FDA 510(k) clearance on 1998-12-17. The listed applicant is Bio-Rad. The 510(k) number is K984268.

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

VARIANT II HEMOGLOBIN A1C PROGRAM received FDA 510(k) clearance on 1998-12-17, under 510(k) number K984268.

Who is the listed applicant for VARIANT II HEMOGLOBIN A1C PROGRAM?

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

What is the FDA product code for VARIANT II HEMOGLOBIN A1C PROGRAM?

The FDA product code for VARIANT II HEMOGLOBIN A1C 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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