510(k) K782033

CARDIAC CARE Q/C TEST KIT by Instrumentation Laboratory CO — Product Code DRL

K782033 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "CARDIAC CARE Q/C TEST KIT". The FDA issued a decision of Substantially Equivalent on December 15, 1978. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.