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FDA 510(k)

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529

K-Number: K020610 · 2002-04-22

ApplicantBio-Rad
Decision Date2002-04-22
Product CodeDIE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2002-04-22 under 510(k) number K020610. The device is classified under product code DIE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529?

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 is a medical device that received FDA 510(k) clearance on 2002-04-22. The listed applicant is Bio-Rad. The 510(k) number is K020610.

When did LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 receive FDA 510(k) clearance?

LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 received FDA 510(k) clearance on 2002-04-22, under 510(k) number K020610.

Who is the listed applicant for LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529?

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 LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529?

The FDA product code for LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 is DIE.

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Other records listing Bio-Rad as applicant

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Related Devices (Code: DIE)

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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