510(k) K811756

THERAPEUTIC DRUG CONTROL by Icl Scientific — Product Code DIF

K811756 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 July 15, 1981. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Mixture Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type