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Clearview Exact II Influenza a & B Test

by Alere Scarborough, Inc D/B/A Binax, Inc. 510(k)

Active United States

510(k) K103610

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK103610 Date6 Jan 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
PSZ
Device Class
Class II
Regulation
21 CFR Part 866.3328
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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