Immunostics Inc., - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) cleared devices by Immunostics Inc., Hematology ✕
8 devices
Cleared
Nov 16, 2018
hemochroma PLUS System
Hematology
84d
Cleared
Sep 08, 2017
hemochroma PLUS System
Hematology
270d
Cleared
Aug 08, 2017
AFIAS iFOB with AFIAS-50
Hematology
264d
Cleared
Jun 14, 2017
hema-screen SPECIFIC Gold
Hematology
23d
Cleared
Jan 17, 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
Hematology
29d
Cleared
Jan 28, 2011
HEMA SCREEN ER
Hematology
135d
Cleared
Jun 06, 2006
HEMA SCREEN SPECIFIC IFOBT
Hematology
104d
Cleared
Dec 06, 1999
COLON ALERT TEST
Hematology
111d