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FDA 510(k)

OXOID PBP2 1 LATEX AGGLUTINATION TEST

K-Number: K011710 · 2002-04-02

ApplicantOxoid , Ltd.
Decision Date2002-04-02
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OXOID PBP2 1 LATEX AGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid , Ltd.. It received FDA 510(k) clearance on 2002-04-02 under 510(k) number K011710. The device is classified under product code MYI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXOID PBP2 1 LATEX AGGLUTINATION TEST?

OXOID PBP2 1 LATEX AGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 2002-04-02. The listed applicant is Oxoid , Ltd.. The 510(k) number is K011710.

When did OXOID PBP2 1 LATEX AGGLUTINATION TEST receive FDA 510(k) clearance?

OXOID PBP2 1 LATEX AGGLUTINATION TEST received FDA 510(k) clearance on 2002-04-02, under 510(k) number K011710.

Who is the listed applicant for OXOID PBP2 1 LATEX AGGLUTINATION TEST?

The FDA 510(k) record lists Oxoid , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXOID PBP2 1 LATEX AGGLUTINATION TEST?

The FDA product code for OXOID PBP2 1 LATEX AGGLUTINATION TEST is MYI.

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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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