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

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
31 to 40 of 416 results
Decision Date To: 05/31/2024
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
results per page
New Search
Download Files | More About De Novo
Device Name
sort by device name [a-z]
sort by device name [z-a]
Requester
sort by requester [a-z]
sort by requester [z-a]
De Novo
Number
sort by DeNovo number [0-9]
sort by DeNovo number [9-0]
510(k)
Number
sort by 510(K) number [0-9]
sort by 510(K) number [9-0]
Decision
Date
sort by decision date [0-9]
sort by decision date [9-0]
QUANTITATION OF ORGANOPHOSPHATE METABOL CENTERS FOR DISEASE CONTROL AND PREVENTI DEN130005 K122282 08/08/2013
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics DEN130002 K121291 05/23/2013
DEKA ARM SYSTEM DEKA INTEGRATED SOLUTIONS CORPORATION DEN120016 K121215 05/09/2014
EEVA 2.0 AUXOGYN, INC. DEN120015 K120427 06/06/2014
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC DEN120013 K113358 04/30/2012
CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTI DEN120012 K113336 05/24/2012
PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. DEN120011 K113070 07/10/2012
NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC DEN110019 K112711 07/15/2013
-
-