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, Cannabinoids
510(k) Number K040257
Device Name QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
Applicant
Quest Diagnostics, Inc.
4230 Burnham Ave.
Las Vegas,  NV  89119 -5410
Applicant Contact PATRICK CARPENTER
Correspondent
Quest Diagnostics, Inc.
4230 Burnham Ave.
Las Vegas,  NV  89119 -5410
Correspondent Contact PATRICK CARPENTER
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received02/04/2004
Decision Date 06/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-