• 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 c. difficile toxin gene amplification assay
510(k) Number K123355
Device Name AMPLIVUE C. DIFFICILE ASSAY
Applicant
QUIDEL CORPORATION
10165 MCKELLAR COURT
san diego,  CA  92121
Applicant Contact ronald h lollar
Correspondent
QUIDEL CORPORATION
10165 MCKELLAR COURT
san diego,  CA  92121
Correspondent Contact ronald h lollar
Regulation Number866.3130
Classification Product Code
OZN  
Date Received10/31/2012
Decision Date 12/13/2012
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
-
-