• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

  • 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 positive blood culture identification and ast kit
De Novo Number DEN160032
Device Name Accelerate Pheno system, Accelerate Phenotest BC Kit
3950 s. country club road #470
tucson,  AZ  85714
Contact maureen mende
Regulation Number866.1650
Classification Product Code
Date Received07/11/2016
Decision Date 02/23/2017
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct