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FDA 510(k)

CLEARVIEW EXACT II INFLUENZA A & B TEST

K-Number: K092349 · 2010-05-10

ApplicantInverness Medical, Inc.
Decision Date2010-05-10
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW EXACT II INFLUENZA A & B TEST is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical, Inc.. It received FDA 510(k) clearance on 2010-05-10 under 510(k) number K092349. 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 CLEARVIEW EXACT II INFLUENZA A & B TEST?

CLEARVIEW EXACT II INFLUENZA A & B TEST is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Inverness Medical, Inc.. The 510(k) number is K092349.

When did CLEARVIEW EXACT II INFLUENZA A & B TEST receive FDA 510(k) clearance?

CLEARVIEW EXACT II INFLUENZA A & B TEST received FDA 510(k) clearance on 2010-05-10, under 510(k) number K092349.

Who is the listed applicant for CLEARVIEW EXACT II INFLUENZA A & B TEST?

The FDA 510(k) record lists Inverness Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARVIEW EXACT II INFLUENZA A & B TEST?

The FDA product code for CLEARVIEW EXACT II INFLUENZA A & B TEST is PSZ.

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Official Source

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