510(k) K980185

COLORPAC TOXIN A by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LLH

K980185 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "COLORPAC TOXIN A". The FDA issued a decision of Substantially Equivalent on July 17, 1998. The device falls under product code LLH (Reagents, Clostridium Difficile Toxin), a Class I device regulated under 21 CFR 866.2660. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.