Binax Equate Glycohemoglobin

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K874749 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• Binax Now Rsv Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065

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  FDA 510(k) K032166 Active Cleared 21 Oct 2003

• Binaxnow PBP2A Test, Model 890-000

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• Binax Equate Strep B

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  FDA 510(k) K872904 Active Cleared 20 Nov 1987

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  Class II

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• Equate AQR APO AL/B Duo Control

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See all devices from Binax, Inc. →