FDA 510(k) Applications Submitted by Beth Lingenfelter
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K120267 |
01/30/2012 |
FILMARRAY RP PANEL |
IDAHO TECHNOLOGY, INC. |
K220407 |
02/14/2022 |
Visby Medical Sexual Health Test |
Visby Medical |
K140407 |
02/18/2014 |
FILMARRAY GASTROINTESTINAL (GI) PANEL |
Biofire Diagnostics |
K110764 |
03/18/2011 |
FILMARRAY RP PANEL |
IDAHO TECHNOLOGY, INC. |
K130914 |
04/02/2013 |
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL |
BIOFIRE DIAGNOSTICS, INC. |
K071188 |
04/30/2007 |
MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM |
IDAHO TECHNOLOGY, INC. |
K051713 |
06/27/2005 |
JBAIDS ANTHRAC DETECTION SYSTEM |
IDAHO TECHNOLOGY, INC. |
K072547 |
09/10/2007 |
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 |
IDAHO TECHNOLOGY, INC. |
K072631 |
09/18/2007 |
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 |
IDAHO TECHNOLOGY, INC. |
K103175 |
10/28/2010 |
FILMARRAY RESPIRATORY PANEL (RP) |
IDAHO TECHNOLOGY, INC. |
K103207 |
11/01/2010 |
JBAIDS Q FEVER DETECTION KIT |
IDAHO TECHNOLOGY, INC. |
K123620 |
11/23/2012 |
FILMARRAY RESPIRATORY PANEL (RP) |
BIOFIRE DIAGNOSTICS, INC. |
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