510(k) K822777

THERAPEUTIC DRUG CONTROL by Icl Scientific — Product Code DIF

K822777 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "THERAPEUTIC DRUG CONTROL". The FDA issued a decision of Substantially Equivalent on October 8, 1982. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Icl Scientific has at least 10 other 510(k) clearances on record.