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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K213403

Aptiva CTD Essential Reagent · Inova Diagnostics, Inc. · decided 2023-09-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Aptiva® CTD Essential Reagent723100INOVA DIAGNOSTICS, INC.LIM LKO LKP LLL LSW MQA OBE08430793040051