510(k) K122584

HEMOSIL READIPLAS TIN by Instrumentation Laboratory CO — Product Code GJS

K122584 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "HEMOSIL READIPLAS TIN". The FDA issued a decision of Substantially Equivalent on March 24, 2013. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.