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

Clearance record K092181

HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS · Instrumentation Laboratory CO · decided 2010-03-11 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
QUANTA Flash® aCL IgM Controls701237INOVA DIAGNOSTICS, INC.JJX08426950594994
QUANTA Flash® aCL IgM Reagents701235INOVA DIAGNOSTICS, INC.MID08426951289240
QUANTA Flash® aCL IgG Reagents701233INOVA DIAGNOSTICS, INC.MID08426950544203
QUANTA Flash® aCL IgG Controls701232INOVA DIAGNOSTICS, INC.JJX08426950554486
QUANTA Flash® aCL IgM Reagents701238INOVA DIAGNOSTICS, INC.MID08426950544210
QUANTA Flash® aCL IgG Reagents701230INOVA DIAGNOSTICS, INC.MID08426951289295