• 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 NumberK142353
Test Name Clinical Reference Laboratory, CRLstat Onsite Drug Test Cup  
Manufacturer NameW.H.P.M., Inc.
Consumer Information Phone Number1(800)445-6917
Test TypeCocaine metabolites
Effective Date07/02/2019
Device Classification Name enzyme immunoassay, cocaine and cocaine metabolites
510(k) Number K142353
Device Name First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test
Applicant
W.H.P.M., Inc.
5358 Irwindale Ave
Irwindale,  CA  91706
Applicant Contact John Wan
Correspondent
LSI INTERNATIONAL INC.
504 EAST DIAMOND AVE. SUITE I
GAITHERSBURG,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3250
Classification Product Code
DIO  
Subsequent Product Codes
DKZ   LDJ  
Date Received08/21/2014
Decision Date 10/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-