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, Nicotine And Nicotine Metabolites
510(k) Number K021944
Device Name COZART EIA COTININE URINE KIT
Applicant
COZART BIOSCIENCE LTD.
45 MILTON PARK
ABINGDON
OXFORDSHIRE OX14 4RU,  GB OX14 4RU
Applicant Contact ROBERTO LIDDI
Correspondent
COZART BIOSCIENCE LTD.
45 MILTON PARK
ABINGDON
OXFORDSHIRE OX14 4RU,  GB OX14 4RU
Correspondent Contact ROBERTO LIDDI
Regulation Number862.3220
Classification Product Code
MKU  
Date Received06/13/2002
Decision Date 05/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-