510(k) K012907

LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL by Clinical Controls — Product Code DIF

K012907 is an FDA 510(k) premarket notification submitted by Clinical Controls for the device "LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL". The FDA issued a decision of Substantially Equivalent on September 28, 2001. The device falls under product code DIF (Drug Mixture Control Materials), a Class I device regulated under 21 CFR 862.3280. Clinical Controls has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2001
Date Received
August 29, 2001
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