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FDA 510(k)

RADIAS MONOCLONAL HBA 1C ASSAY

K-Number: K935613 · 1994-04-05

ApplicantBio-Rad
Decision Date1994-04-05
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RADIAS MONOCLONAL HBA 1C ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1994-04-05 under 510(k) number K935613. 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 RADIAS MONOCLONAL HBA 1C ASSAY?

RADIAS MONOCLONAL HBA 1C ASSAY is a medical device that received FDA 510(k) clearance on 1994-04-05. The listed applicant is Bio-Rad. The 510(k) number is K935613.

When did RADIAS MONOCLONAL HBA 1C ASSAY receive FDA 510(k) clearance?

RADIAS MONOCLONAL HBA 1C ASSAY received FDA 510(k) clearance on 1994-04-05, under 510(k) number K935613.

Who is the listed applicant for RADIAS MONOCLONAL HBA 1C ASSAY?

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 RADIAS MONOCLONAL HBA 1C ASSAY?

The FDA product code for RADIAS MONOCLONAL HBA 1C ASSAY 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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