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FDA 510(k)

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945

K-Number: K033387 · 2003-12-02

ApplicantBio-Rad
Decision Date2003-12-02
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2003-12-02 under 510(k) number K033387. 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 SERUM CHEMISTRY CONTROL, MODELS 935 AND 945?

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 is a medical device that received FDA 510(k) clearance on 2003-12-02. The listed applicant is Bio-Rad. The 510(k) number is K033387.

When did QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 receive FDA 510(k) clearance?

QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 received FDA 510(k) clearance on 2003-12-02, under 510(k) number K033387.

Who is the listed applicant for QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945?

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 SERUM CHEMISTRY CONTROL, MODELS 935 AND 945?

The FDA product code for QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 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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