Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Solana Bordetella Complete Assay

K-Number: K181029 · 2018-07-15

ApplicantQuidel Corporation
Decision Date2018-07-15
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Solana Bordetella Complete Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2018-07-15 under approval number K181029. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solana Bordetella Complete Assay?

Solana Bordetella Complete Assay is a medical device that received FDA 510(k) clearance on 2018-07-15. It is manufactured by Quidel Corporation. The 510(k) number is K181029.

When was Solana Bordetella Complete Assay approved by the FDA?

Solana Bordetella Complete Assay received FDA 510(k) clearance on 2018-07-15, under approval number K181029.

What company makes Solana Bordetella Complete Assay?

Solana Bordetella Complete Assay is manufactured by Quidel Corporation.

What is the FDA product code for Solana Bordetella Complete Assay?

The FDA product code for Solana Bordetella Complete Assay is OZZ.

Other Devices by Quidel Corporation

K162451Solana HSV 1+2/VZV Assay K162274Solana Strep Complete Assay K161814Solana Influenza A+B Assay K161182Solana Trichomonas Assay K153012Sofia Influenza A+B FIA K171976Sofia Strep A+ FIA, Sofia 2 Analyzer

View all 23 devices →

Related Devices (Code: OZZ)

K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation K170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc. K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.

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.

↑