• 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 NumberK051966
Test Name Worldwide Medical First Check Multi Drug Cup 7  (OTC)
Manufacturer NameWORLDWIDE MEDICAL LLC
Consumer Information Phone Number(888)788-5716
Test TypePhencyclidine (PCP)
Effective Date11/29/2005
Device Classification Name enzyme immunoassay, amphetamine
510(k) Number K051966
Device Name FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
Applicant
WORLDWIDE MEDICAL LLC
13 SPECTRUM POINTE DR.
LAKE FOREST,  CA  92630
Applicant Contact KEVIN J GADAWSKI
Correspondent
WORLDWIDE MEDICAL LLC
13 SPECTRUM POINTE DR.
LAKE FOREST,  CA  92630
Correspondent Contact KEVIN J GADAWSKI
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   LAF   LCM   LDJ  
Date Received07/20/2005
Decision Date 09/07/2005
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
-
-