510(k) K982442

C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) by Care Wise Medical Products Corp. — Product Code IZD

K982442 is an FDA 510(k) premarket notification submitted by Care Wise Medical Products Corp. for the device "C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)". The FDA issued a decision of Substantially Equivalent on August 25, 1998. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Care Wise Medical Products Corp. has at least 3 other 510(k) clearances on record.