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FDA 510(k)

AMPLIVUE GBS ASSAY

K-Number: K133503 · 2013-12-20

ApplicantQuidel Corporation
Decision Date2013-12-20
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMPLIVUE GBS ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2013-12-20 under 510(k) number K133503. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLIVUE GBS ASSAY?

AMPLIVUE GBS ASSAY is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Quidel Corporation. The 510(k) number is K133503.

When did AMPLIVUE GBS ASSAY receive FDA 510(k) clearance?

AMPLIVUE GBS ASSAY received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133503.

Who is the listed applicant for AMPLIVUE GBS ASSAY?

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

What is the FDA product code for AMPLIVUE GBS ASSAY?

The FDA product code for AMPLIVUE GBS ASSAY is NJR.

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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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