Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back to Search Results
Document NumberK151213
Test Name UCP Biosciences, Inc. UCP Drug Test Mini Cups  
Manufacturer NameUCP BIOSCIENCES, INC
Consumer Information Phone Number(408)392-0064
Test TypeCannabinoids (THC)
Effective Date08/31/2015
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K151213
Device Name UCP Drug Test Mini Cups
Applicant
UCP BIOSCIENCES, INC
1445 KOLL CIRCLE, STE 111
SAN JOSE,  CA  95112
Applicant Contact NANCY CHEN
Correspondent
UCP BIOSCIENCES, INC
1445 KOLL CIRCLE, STE 111
SAN JOSE,  CA  95112
Correspondent Contact NANCY CHEN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LCM   LDJ   LFG  
Date Received05/06/2015
Decision Date 08/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-