FDA 510(k) Applications Submitted by DIAMOND DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K071039 |
04/12/2007 |
MISSION OLYMPUS AU ISE CALIBRATORS |
DIAMOND DIAGNOSTICS, INC. |
| K121040 |
04/05/2012 |
SMARTLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
| K093357 |
10/28/2009 |
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D |
DIAMOND DIAGNOSTICS, INC. |
| K093384 |
10/30/2009 |
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) |
DIAMOND DIAGNOSTICS, INC. |
| K093492 |
11/10/2009 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR |
DIAMOND DIAGNOSTICS, INC. |
| K124009 |
12/27/2012 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C |
DIAMOND DIAGNOSTICS, INC. |
| K082462 |
08/27/2008 |
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ |
DIAMOND DIAGNOSTICS, INC. |
| K102959 |
10/05/2010 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
| K020596 |
02/22/2002 |
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS |
DIAMOND DIAGNOSTICS, INC. |
| K033055 |
09/29/2003 |
GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS |
DIAMOND DIAGNOSTICS, INC. |
| K031159 |
04/14/2003 |
CALIBRATING MATERIAL, CALIBRATING STANDARDS |
DIAMOND DIAGNOSTICS, INC. |
| K033056 |
09/29/2003 |
BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT |
DIAMOND DIAGNOSTICS, INC. |
| K033058 |
09/29/2003 |
CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS |
DIAMOND DIAGNOSTICS, INC. |
| K033060 |
09/29/2003 |
CALIBRATING MATERIAL, CALIBRATING STANDARDS |
DIAMOND DIAGNOSTICS, INC. |
| K033061 |
09/29/2003 |
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE |
DIAMOND DIAGNOSTICS, INC. |
| K033063 |
09/29/2003 |
MISSION CONTROLS |
DIAMOND DIAGNOSTICS, INC. |
| K013850 |
11/20/2001 |
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE |
DIAMOND DIAGNOSTICS, INC. |
| K070104 |
01/10/2007 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
| K060206 |
01/26/2006 |
MISSION COMPLETE |
DIAMOND DIAGNOSTICS, INC. |
| K062674 |
09/08/2006 |
MISSION TRINITY B |
DIAMOND DIAGNOSTICS, INC. |
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