Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Diamond Diagnostics, Inc. — Predicate Candidate Screening

26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

123 daysmedian FDA review time
242 days90th percentile
26clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.2020-10-012120
K133751DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICSDiamond Diagnostics, Inc.2014-08-082420
K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSDiamond Diagnostics, Inc.2013-04-171110
K121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHDiamond Diagnostics, Inc.2012-12-202600
K121040SMARTLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.2012-08-301470
K121140PROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.2012-08-221280
K120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2Diamond Diagnostics, Inc.2012-04-17490
K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEDiamond Diagnostics, Inc.2011-05-061710
K102959PROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.2011-01-141010
K093357DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMONDiamond Diagnostics, Inc.2010-06-242390
K093492MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISDiamond Diagnostics, Inc.2010-03-191290
K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,Diamond Diagnostics, Inc.2010-03-101310
K082462GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+Diamond Diagnostics, Inc.2009-02-061630
K070104PROLYTE ELECTROLYTE ANALYZERDiamond Diagnostics, Inc.2008-05-074830
K071039MISSION OLYMPUS AU ISE CALIBRATORSDiamond Diagnostics, Inc.2007-08-081180
K062674MISSION TRINITY BDiamond Diagnostics, Inc.2006-12-01840
K060206MISSION COMPLETEDiamond Diagnostics, Inc.2006-03-21540
K033060CALIBRATING MATERIAL, CALIBRATING STANDARDSDiamond Diagnostics, Inc.2004-03-041570
K033058CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYDiamond Diagnostics, Inc.2004-01-301230
K033055GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSDiamond Diagnostics, Inc.2004-01-301230
K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTDiamond Diagnostics, Inc.2004-01-301230
K033063MISSION CONTROLSDiamond Diagnostics, Inc.2003-12-12740
K033061CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCEDiamond Diagnostics, Inc.2003-11-07390
K031159CALIBRATING MATERIAL, CALIBRATING STANDARDSDiamond Diagnostics, Inc.2003-06-25720
K020596CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDSDiamond Diagnostics, Inc.2002-03-23290
K013850STANDARD A, STANDARD B, STANDARD C, CAL, SLOPEDiamond Diagnostics, Inc.2001-12-21310

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda