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 System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
510(k) Number K062864
Device Name MASTALEX -MRSA, MODEL RST501
Applicant
Mast Group , Ltd.
Mast House, Derby Rd.
Bootle, Merseyside,  GB L20 1EA
Applicant Contact BARBARA A LEE
Correspondent
Mast Group , Ltd.
Mast House, Derby Rd.
Bootle, Merseyside,  GB L20 1EA
Correspondent Contact BARBARA A LEE
Regulation Number866.1640
Classification Product Code
MYI  
Date Received09/25/2006
Decision Date 10/18/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-