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DIAMOND DIAGNOSTICS Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30030307933003030793DIAMOND DIAGNOSTICS Inc1N2026-01-01333 Fiske St Holliston MA US 01746

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1005482061447043K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM2020-10-01
1005481302064148K133751DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDSJIT2014-08-08
1005481199605392K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION CJJY2013-04-17
1005482026707327K121140PROLYTE ELECTROLYTE ANALYZERJGS2012-08-22
1005481179639257K121040SMARTLYTE ELECTROLYTE ANALYZERCEM2012-08-30
1005481430250727K121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGHJIT2012-12-20
1005481643654155K120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2JIT2012-04-17
1005481500283008K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVELJJY2011-05-06
1005481922172893K102959PROLYTE ELECTROLYTE ANALYZERJGS2011-01-14
1005481918317001K093492MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATORJJY2010-03-19
1005481045427099K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)JJY2010-03-10
1005481896028398K093357DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410DJIT2010-06-24
1005481864144479K082462GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+JGS2009-02-06
1005481653469678K071039MISSION OLYMPUS AU ISE CALIBRATORSJIT2007-08-08
1005481243098623K070104PROLYTE ELECTROLYTE ANALYZERJGS2008-05-07
1005481406421254K062674MISSION TRINITY BJJY2006-12-01
1005481924802895K060206MISSION COMPLETEJJY2006-03-21
1005481853706841K033063MISSION CONTROLSJJS2003-12-12
1005481612313489K033061CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCEJIX2003-11-07
1005481374161736K033060CALIBRATING MATERIAL, CALIBRATING STANDARDSJIT2004-03-04
1005482004676743K033058CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSCGX2004-01-30
1005481556762453K033056BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENTCDS2004-01-30
1005481505978563K033055GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMSCGA2004-01-30
1005481712121466K031159CALIBRATING MATERIAL, CALIBRATING STANDARDSJIT2003-06-25
1005481103651210K022027CALIBRATING MATERIAL, BUFFERS, STANDARDJIT2002-07-22
1005481320483828K020894CALIBRATING MATERIAL, CAL-PAK, BUFFERSJIT2002-04-29
1005481604716464K020596CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDSJIT2002-03-23
1005481546786905K013850STANDARD A, STANDARD B, STANDARD C, CAL, SLOPEJIT2001-12-21
1005481399760980
1005481570269122
1005481826485845
1005481890030969
1005481964622248
1005482019056942

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JIT112014-08-08
JJY62013-04-17
JGS42012-08-22
CEM22020-10-01
CDS12004-01-30
CGA12004-01-30
CGX12004-01-30
JJS12003-12-12
JIX12003-11-07

PMN#

GUDID#

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