510(k) K132812

UCP MULTI-DRUG TEST KEY CUPS by Ucp Biosciences, Inc. — Product Code DKZ

K132812 is an FDA 510(k) premarket notification submitted by Ucp Biosciences, Inc. for the device "UCP MULTI-DRUG TEST KEY CUPS". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Ucp Biosciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2014
Date Received
September 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type