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FDA 510(k)

VARIANT HEMOGLOBINOPATHY PROGRAM

K-Number: K954048 · 1995-11-20

ApplicantBio-Rad
Decision Date1995-11-20
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT HEMOGLOBINOPATHY 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 1995-11-20 under 510(k) number K954048. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIANT HEMOGLOBINOPATHY PROGRAM?

VARIANT HEMOGLOBINOPATHY PROGRAM is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Bio-Rad. The 510(k) number is K954048.

When did VARIANT HEMOGLOBINOPATHY PROGRAM receive FDA 510(k) clearance?

VARIANT HEMOGLOBINOPATHY PROGRAM received FDA 510(k) clearance on 1995-11-20, under 510(k) number K954048.

Who is the listed applicant for VARIANT HEMOGLOBINOPATHY 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 HEMOGLOBINOPATHY PROGRAM?

The FDA product code for VARIANT HEMOGLOBINOPATHY PROGRAM is GKA.

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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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