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FDA 510(k)

RADIAS ANA SCREEN ENZYME IMMUNOASSAY

K-Number: K941509 · 1994-06-30

ApplicantBio-Rad
Decision Date1994-06-30
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RADIAS ANA SCREEN ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1994-06-30 under 510(k) number K941509. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAS ANA SCREEN ENZYME IMMUNOASSAY?

RADIAS ANA SCREEN ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-06-30. The listed applicant is Bio-Rad. The 510(k) number is K941509.

When did RADIAS ANA SCREEN ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

RADIAS ANA SCREEN ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1994-06-30, under 510(k) number K941509.

Who is the listed applicant for RADIAS ANA SCREEN ENZYME IMMUNOASSAY?

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 ANA SCREEN ENZYME IMMUNOASSAY?

The FDA product code for RADIAS ANA SCREEN ENZYME IMMUNOASSAY is LJM.

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Related Devices (Code: LJM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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