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FDA 510(k)

LYPHOCHEK WHOLE BLOOD CONTROL

K-Number: K980871 · 1998-04-06

ApplicantBio-Rad
Decision Date1998-04-06
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK WHOLE BLOOD CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-04-06 under 510(k) number K980871. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK WHOLE BLOOD CONTROL?

LYPHOCHEK WHOLE BLOOD CONTROL is a medical device that received FDA 510(k) clearance on 1998-04-06. The listed applicant is Bio-Rad. The 510(k) number is K980871.

When did LYPHOCHEK WHOLE BLOOD CONTROL receive FDA 510(k) clearance?

LYPHOCHEK WHOLE BLOOD CONTROL received FDA 510(k) clearance on 1998-04-06, under 510(k) number K980871.

Who is the listed applicant for LYPHOCHEK WHOLE BLOOD CONTROL?

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 CONTROL?

The FDA product code for LYPHOCHEK WHOLE BLOOD CONTROL is DIF.

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Related Devices (Code: DIF)

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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