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FDA 510(k)

LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580

K-Number: K992172 · 1999-09-02

ApplicantBio-Rad
Decision Date1999-09-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1999-09-02 under 510(k) number K992172. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580?

LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 is a medical device that received FDA 510(k) clearance on 1999-09-02. The listed applicant is Bio-Rad. The 510(k) number is K992172.

When did LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 receive FDA 510(k) clearance?

LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 received FDA 510(k) clearance on 1999-09-02, under 510(k) number K992172.

Who is the listed applicant for LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580?

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 TUMOR MARKER CONTROL, MODEL 580?

The FDA product code for LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 is JJY.

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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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