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FDA 510(k)

BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST

K-Number: K811710 · 1981-07-15

ApplicantBio-Rad
Decision Date1981-07-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1981-07-15 under 510(k) number K811710. 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 BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST?

BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST is a medical device that received FDA 510(k) clearance on 1981-07-15. The listed applicant is Bio-Rad. The 510(k) number is K811710.

When did BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST receive FDA 510(k) clearance?

BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST received FDA 510(k) clearance on 1981-07-15, under 510(k) number K811710.

Who is the listed applicant for BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST?

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 BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST?

The FDA product code for BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST 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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