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

CLIA - Clinical Laboratory Improvement Amendments
  • 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
Test System NameTotal Diagnostic Solutions Multi-Drug of Abuse Urine Test  
Document NumberK063545
Parent Document NumberK063545
Analyte NameBenzodiazepines
Analyte SpecialtyToxicology / TDM
ComplexityWAIVED
Effective Date07/04/2010
Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K063545
Device Name MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
Applicant
Alfa Scientific Designs, Inc.
13200 Gregg St.
Powat,  CA  92064
Applicant Contact DAITING RONG
Correspondent
Alfa Scientific Designs, Inc.
13200 Gregg St.
Powat,  CA  92064
Correspondent Contact DAITING RONG
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DKZ  
JXM   LCM   LDJ   LFG   NFV  
Date Received11/24/2006
Decision Date 05/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-