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FDA 510(k)

QUEST TUMOR MARKER CONTROL, MODEL 955

K-Number: K042815 · 2004-11-05

ApplicantBio-Rad
Decision Date2004-11-05
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUEST TUMOR MARKER CONTROL, MODEL 955 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2004-11-05 under 510(k) number K042815. 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 QUEST TUMOR MARKER CONTROL, MODEL 955?

QUEST TUMOR MARKER CONTROL, MODEL 955 is a medical device that received FDA 510(k) clearance on 2004-11-05. The listed applicant is Bio-Rad. The 510(k) number is K042815.

When did QUEST TUMOR MARKER CONTROL, MODEL 955 receive FDA 510(k) clearance?

QUEST TUMOR MARKER CONTROL, MODEL 955 received FDA 510(k) clearance on 2004-11-05, under 510(k) number K042815.

Who is the listed applicant for QUEST TUMOR MARKER CONTROL, MODEL 955?

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 QUEST TUMOR MARKER CONTROL, MODEL 955?

The FDA product code for QUEST TUMOR MARKER CONTROL, MODEL 955 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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