Diamond Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+, DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C
26
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diamond Diagnostics, Inc. Chemistry ✕
26 devices
Cleared
Oct 01, 2020
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Chemistry
212d
Cleared
Aug 08, 2014
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
Chemistry
242d
Cleared
Apr 17, 2013
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK...
Chemistry
111d
Cleared
Dec 20, 2012
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH
Chemistry
260d
Cleared
Aug 30, 2012
SMARTLYTE ELECTROLYTE ANALYZER
Chemistry
147d
Cleared
Aug 22, 2012
PROLYTE ELECTROLYTE ANALYZER
Chemistry
128d
Cleared
Apr 17, 2012
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2
Chemistry
49d
Cleared
May 06, 2011
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
Chemistry
171d
Cleared
Jan 14, 2011
PROLYTE ELECTROLYTE ANALYZER
Chemistry
101d
Cleared
Jun 24, 2010
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE...
Chemistry
239d
Cleared
Mar 19, 2010
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL...
Chemistry
129d
Cleared
Mar 10, 2010
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)
Chemistry
131d