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FDA 510(k)

OSOM INFLUENZA A&B TEST , MODEL PN190

K-Number: K092633 · 2009-09-25

ApplicantGenzyme Corporation
Decision Date2009-09-25
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OSOM INFLUENZA A&B TEST , MODEL PN190 is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corporation. It received FDA 510(k) clearance on 2009-09-25 under 510(k) number K092633. 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 , MODEL PN190?

OSOM INFLUENZA A&B TEST , MODEL PN190 is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Genzyme Corporation. The 510(k) number is K092633.

When did OSOM INFLUENZA A&B TEST , MODEL PN190 receive FDA 510(k) clearance?

OSOM INFLUENZA A&B TEST , MODEL PN190 received FDA 510(k) clearance on 2009-09-25, under 510(k) number K092633.

Who is the listed applicant for OSOM INFLUENZA A&B TEST , MODEL PN190?

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

What is the FDA product code for OSOM INFLUENZA A&B TEST , MODEL PN190?

The FDA product code for OSOM INFLUENZA A&B TEST , MODEL PN190 is PSZ.

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Official Source

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