|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
WIDEXLINK IN CLEAR SERIES HEARING AIDS
|
OFFICE RESEARCH IN CLINICAL AMPLIFICTION |
DEN100025 |
K101699 |
03/31/2011 |
DENV DETECT IGM CAPTURE ELISA
|
INBIOS INTL., INC. |
DEN100020 |
K100534 |
04/08/2011 |
APTIMA TRICHOMONAS VAGINALIS ASSAY
|
GEN-PROBE INCORPORATED |
DEN110012 |
K102911 |
04/19/2011 |
LIPFLOW THERMAL PULSATION SYSTEM (FORMER
|
TEARSCIENCE, INC. |
DEN100017 |
K093937 |
06/28/2011 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR
|
APTUS ENDOSYSTEMS, INC. |
DEN100026 |
K102333 |
11/21/2011 |
INFRASCANNER, MODEL 1000
|
INFRASCAN, INC. |
DEN100002 |
K080377 |
12/13/2011 |
VIOGUARD SELF-SANITIZING KEYBOARD, MODEL
|
VIOGUARD |
DEN100013 |
K092996 |
12/20/2011 |
STRATIFY JCV(TM) ANTIBODY
|
FOCUS DIAGNOSTICS, INC. |
DEN120008 |
K112394 |
01/20/2012 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C
|
PHADIA US INC. |
DEN120001 |
K103039 |
02/15/2012 |
SYSTEM 1E PROCESS BIOLOGICAL MONITORING
|
STERIS Corporation |
DEN110002 |
K100049 |
03/30/2012 |