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 a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-12-21 under approval 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. It is manufactured by Quidel Corporation. The 510(k) number is K173250.
When was Solana GBS Assay approved by the FDA?
Solana GBS Assay received FDA 510(k) clearance on 2017-12-21, under approval number K173250.
What company makes Solana GBS Assay?
Solana GBS Assay is manufactured by Quidel Corporation.
What is the FDA product code for Solana GBS Assay?
The FDA product code for Solana 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.