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 hsv-1 and hsv-2 cns nucleic-acid based panel
510(k) Number K141458
Device Name SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
Applicant
FOCUS DIAGNOSTICS
11331 Valley View Street
CYPRESS,  CA  90630
Applicant Contact SHARON YOUNG
Correspondent
FOCUS DIAGNOSTICS
11331 Valley View Street
CYPRESS,  CA  90630
Correspondent Contact SHARON YOUNG
Regulation Number866.3307
Classification Product Code
PGH  
Date Received06/02/2014
Decision Date 07/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-