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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 the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2018-07-15 under 510(k) 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. The listed applicant is Quidel Corporation. The 510(k) number is K181029.

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

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

Who is the listed applicant for Solana Bordetella Complete 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 Bordetella Complete Assay?

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

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Related Devices (Code: OZZ)

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.

K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex CorporationK170284Great Basin Bordetella Direct TestGreat Basin Scientific, 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.

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