510(k) K020845

EMIT 2000 VANCOMYCIN CALIBRATORS by Dade Behring, Inc. — Product Code DLJ

K020845 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "EMIT 2000 VANCOMYCIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on May 8, 2002. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.