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FDA 510(k)

ABBOTT PLEX-ID FLU ASSAY

K-Number: K121003 · 2012-12-21

ApplicantAbbott Laboratories
Decision Date2012-12-21
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ABBOTT PLEX-ID FLU ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K121003. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT PLEX-ID FLU ASSAY?

ABBOTT PLEX-ID FLU ASSAY is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Abbott Laboratories. The 510(k) number is K121003.

When did ABBOTT PLEX-ID FLU ASSAY receive FDA 510(k) clearance?

ABBOTT PLEX-ID FLU ASSAY received FDA 510(k) clearance on 2012-12-21, under 510(k) number K121003.

Who is the listed applicant for ABBOTT PLEX-ID FLU ASSAY?

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

What is the FDA product code for ABBOTT PLEX-ID FLU ASSAY?

The FDA product code for ABBOTT PLEX-ID FLU ASSAY is OCC.

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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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