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FDA 510(k)

Solana GBS Assay

K-Number: K173250 · 2017-12-21

ApplicantQuidel Corporation
Decision Date2017-12-21
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Solana 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 2017-12-21 under 510(k) number K173250. 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 Solana GBS Assay?

Solana GBS Assay is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Quidel Corporation. The 510(k) number is K173250.

When did Solana GBS Assay receive FDA 510(k) clearance?

Solana GBS Assay received FDA 510(k) clearance on 2017-12-21, under 510(k) number K173250.

Who is the listed applicant for Solana 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 Solana GBS Assay?

The FDA product code for Solana GBS Assay is NJR.

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Related Devices (Code: NJR)

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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