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 culture media, antimicrobial susceptibility test, excluding mueller hinton agar
510(k) Number K102922
Device Name HARDYCHROM MRSA
Applicant
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Applicant Contact RENE CLASEN
Correspondent
HARDY DIAGNOSTICS
1430 WEST MCCOY LN.
SANTA MARIA,  CA  93455
Correspondent Contact RENE CLASEN
Regulation Number866.1700
Classification Product Code
JSO  
Date Received10/01/2010
Decision Date 05/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-