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FDA 510(k)

GENZYME OSOM INFLUENZA A & B TEST

K-Number: K051244 · 2006-02-21

ApplicantGenzyme Corp.
Decision Date2006-02-21
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENZYME 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 2006-02-21 under 510(k) number K051244. 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 GENZYME OSOM INFLUENZA A & B TEST?

GENZYME OSOM INFLUENZA A & B TEST is a medical device that received FDA 510(k) clearance on 2006-02-21. The listed applicant is Genzyme Corp.. The 510(k) number is K051244.

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

GENZYME OSOM INFLUENZA A & B TEST received FDA 510(k) clearance on 2006-02-21, under 510(k) number K051244.

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

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

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Related Devices (Code: PSZ)

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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