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 NumberK122809
Test Name Medical Distribution Group, Bicycle Health CLIA WAIVED DRUG TEST  
Manufacturer NameADVIN BIOTECH
Consumer Information Phone Number1(844)471-1681
Test TypeAmphetamines
Effective Date05/25/2023
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K122809
Device Name Advin Multi-Drug Screen Test Cassette, Dip Card and Cup
Applicant
ADVIN BIOTECH
6861 NANCY RIDGE DR.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
ADVIN BIOTECH
10140 Mesa Rim Rd.
Unit 1
San Diego,  CA  92121
Correspondent Contact Yuedan Huang
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LCM   LDJ   LFG  
Date Received09/13/2012
Decision Date 06/17/2013
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
-
-