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FDA 510(k)

COLUMN TEST, HEMOGLOBIN A

K-Number: K781948 · 1978-12-20

ApplicantBio-Rad
Decision Date1978-12-20
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLUMN TEST, HEMOGLOBIN A is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781948. 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 COLUMN TEST, HEMOGLOBIN A?

COLUMN TEST, HEMOGLOBIN A is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Bio-Rad. The 510(k) number is K781948.

When did COLUMN TEST, HEMOGLOBIN A receive FDA 510(k) clearance?

COLUMN TEST, HEMOGLOBIN A received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781948.

Who is the listed applicant for COLUMN TEST, HEMOGLOBIN A?

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 COLUMN TEST, HEMOGLOBIN A?

The FDA product code for COLUMN TEST, HEMOGLOBIN A 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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