510(k) K860919

THERACHEM, TDC THERAPEUTIC DRUG CONTROLS by Fisher Scientific Co., LLC — Product Code DIF

K860919 is an FDA 510(k) premarket notification submitted by Fisher Scientific Co., LLC for the device "THERACHEM, TDC THERAPEUTIC DRUG CONTROLS". The FDA issued a decision of Substantially Equivalent on April 11, 1986. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Fisher Scientific Co., LLC has at least 10 other 510(k) clearances on record.