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 NumberK131811
Test Name Transmetron Invitro Pro Drug Test Cups  
Manufacturer NameUCP BIOSCIENCES, INC.
Consumer Information Phone Number(877)474-4097
Test TypeBuprenorphine
Effective Date12/10/2014
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K131811
Device Name UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST 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 Received06/19/2013
Decision Date 07/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-