510(k) K984065

STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK by Dade Behring, Inc. — Product Code DDR

K984065 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK". The FDA issued a decision of Substantially Equivalent on December 14, 1998. The device falls under product code DDR (Myoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5680. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.