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FDA 510(k)

OSOM INFLUENZA A&B TEST

K-Number: K061508 · 2006-06-12

ApplicantGenzyme Corp.
Decision Date2006-06-12
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSOM INFLUENZA A&B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 2006-06-12 under 510(k) number K061508. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSOM INFLUENZA A&B TEST?

OSOM INFLUENZA A&B TEST is a medical device that received FDA 510(k) clearance on 2006-06-12. The listed applicant is Genzyme Corp.. The 510(k) number is K061508.

When did OSOM INFLUENZA A&B TEST receive FDA 510(k) clearance?

OSOM INFLUENZA A&B TEST received FDA 510(k) clearance on 2006-06-12, under 510(k) number K061508.

Who is the listed applicant for OSOM INFLUENZA A&B TEST?

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

What is the FDA product code for OSOM INFLUENZA A&B TEST?

The FDA product code for OSOM INFLUENZA A&B TEST is PSZ.

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Related Devices (Code: PSZ)

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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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