Clearview Exact PBP2A Test, Model 891-000

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K091766 ↗

FDA Product Code

MYI

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Binax, Inc. →