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FDA 510(k)

QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL

K-Number: K050536 · 2005-03-24

ApplicantBio-Rad
Decision Date2005-03-24
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUEST DIAGNOSTICS IMMUNOASSAY/TDM 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 2005-03-24 under 510(k) number K050536. 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 DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL is a medical device that received FDA 510(k) clearance on 2005-03-24. The listed applicant is Bio-Rad. The 510(k) number is K050536.

When did QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL receive FDA 510(k) clearance?

QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL received FDA 510(k) clearance on 2005-03-24, under 510(k) number K050536.

Who is the listed applicant for QUEST DIAGNOSTICS IMMUNOASSAY/TDM 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 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL?

The FDA product code for QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL is JJY.

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Related Devices (Code: JJY)

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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