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 Sep 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 17 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 28, 2001
Date Received
Aug 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
510(k) Exempt

Source: FDA 510(k) database entry for K012907. Report a data issue: hello@regdatalab.com.