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

510(k) Premarket Notification
  • 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
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K014247
Device Name TRIAGE DRUGS OF ABUSE PANEL PLUS PPX, MODEL CATALOG 92002
Applicant
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Applicant Contact JEFFREY R DAHLEN
Correspondent
Biosite Incorporated
11030 Roselle St.
San Diego,  CA  92121
Correspondent Contact JEFFREY R DAHLEN
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJG   JXM   JXN  
LCM   LDJ   LFG  
Date Received12/26/2001
Decision Date 06/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-