510(k) K811811

TDM ANTI-CONVULSANT CONTROL LEVELS I-II by Environmental Chemical Specialties — Product Code DIF

K811811 is an FDA 510(k) premarket notification submitted by Environmental Chemical Specialties for the device "TDM ANTI-CONVULSANT CONTROL LEVELS I-II". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Environmental Chemical Specialties has at least 10 other 510(k) clearances on record.