FDA.reportPublic FDA data

JAS Diagnostics/Drew Scientific

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10646083003071743JAS Diagnostics/Drew Scientific1N2026-01-016600 NW 14th Street BAY 12 Plantation FL US 33313

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
578301371013536K993590FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SETLCP1999-12-21
578302035282366K991539EXCELL 22GKZ1999-07-01
578301695340875K991409K-ASSAY RHEUMATOID FACTORDHR1999-06-09
578301180368001K981339QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3JJY1998-04-21
578301981642147K972004ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSCGZ1997-06-16
578301460352493K970781LIQUID GLUCOSE (OXIDASE) REAGENT SETCGA1997-04-21
578301013241976K954074AALTO SCIENTIFIC LIQUID CARDIAC CONTROLJJY1995-10-07
578301749027667K952720AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & IIJPK1995-09-20
578301977451534K942958CREATINE KINASE MB DETERMINATION (UV)JHW1994-11-21
578301718742469K933287745 GLYCOMATLCP1993-09-09
578301832473779K902616BILIRUBIN CONTROLJJY1990-07-19
578301939794605K882117ETHYL ALCOHOL STANDARDDNN1988-08-04
578301804829635K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYJIY1987-01-21
578301569255906K863832NAPHTHYL PHOSPHATE, ACID PHOSPHATASEJFH1986-12-16
578301128770938K853592MAGNESIUMJGJ1985-09-16
578301009602828K852169CHLORIDE REAGENTCHJ1985-08-21
578301778307766K822471PSI ALBUMIN REAGENTCIX1982-09-14
578301269112197K822469PSI CALCIUM REAGENTCIC1982-09-14
578301088117830K813496LDH-LCFJ1981-12-31
578301910303002K812341UREA NITROGEN (BUN)CDQ1981-09-01
578301249326593K130915XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACKJJE2014-05-15
578301420944899K080468LIASYS WITH MODELS LIASYSCFR2008-07-25
578302016695650K071562D3 HEMATOLOGY ANALYZER, MODEL D3GKZ2007-12-11
578301462382506K070757MICROPROTEIN REAGENT SETJGP2007-12-04
578301972229495K070704TRILOGY ANALYZERCGA2007-07-13
578301414103076K061511R&D CBC-3D + CRP HEMATOLOGY CONTROLJPK2006-07-10
578301707461659K051646ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGHJGS2005-10-07
578301183744473K043378DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITJIT2004-12-29
578301242241995K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITJJX2004-10-29
578301416572422K031539HEMOGLOBIN A1C REAGENT SETLCP2003-08-06
578301657570200K021671JAS HDL CHOLESTEROL (AUTOMATED) REAGENTLBS2002-07-19
578302019310047K020454CHEMISTRY CALIBRATORJIT2002-04-08
578301956325928K020282JAS AMYLASE LIQUID REAGENTJFJ2002-02-28
578301666936174K020129PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULEJIX2002-02-01
578301788098056K013912CREATINE KINASE (CK-NAC)CGS2002-01-18
578301837141747K013698AST (SGOT)CIT2001-12-21
578302032643140K012332JAS CARBON DIOXIDE LIQUID REAGENTKHS2001-09-06
578301306190217K012038JAS URIC ACID LIQUID REAGENTKNK2001-08-21
578301939707440K011900GLUCOSE (HEXOKINASE)CFR2001-07-31
578301028321288K011599ALKALINE PHOSPHATASE LIQUID REAGENTCJE2001-07-20
578301210971102K011596UREA NITROGEN (BUN) LIQUID REAGENTCDQ2001-07-17
578302042038455K011441JAS CALCIUM (ARSENAZO) REAGENTCJY2001-07-09
578301797955713K003991CD-CAL PLUS CALIBRATORKRX2001-01-16
578301961902389K003912PHOSPHORUS REAGENTCEO2001-02-21
578301243768178K003874CBC-4K HEMATOLOGY CONTROLJPK2001-01-12
578301766180622K003835JAS MAGNESIUM REAGENTJGJ2001-03-23
578301023694975K003829TOTAL BILIRUBINCIG2001-02-12
578301112502408K003693DIRECT BILIRUBINCIG2001-01-29
578301456245802K003247CREATININECGX2000-12-14
578301821208999K002651C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SETDCK2000-10-13
578301033638927
578301118664415
578301141518117
578301242011439
578301295051218
578301429608109
578301554485571
578301568632586
578301697857687
578301735810649
578301737185225
578301755384127
578301776179439
578301830418223
578301905237371
578301911051499
578301933931092
578301948946442
578301957137301
578301957176060
578301962091470
578302054318749

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JPK62006-07-10
GKZ32007-12-11
LCP32003-08-06
JJY31998-04-21
CFR22008-07-25
CGA22007-07-13
JIT22004-12-29
CDQ22001-07-17
JGJ22001-03-23
CIG22001-02-12
KRX22001-01-16
JJE12014-05-15
JGP12007-12-04
JGS12005-10-07
JJX12004-10-29
LBS12002-07-19
JFJ12002-02-28
JIX12002-02-01
CGS12002-01-18
CIT12001-12-21
KHS12001-09-06
KNK12001-08-21
CJE12001-07-20
CJY12001-07-09
CEO12001-02-21
CGX12000-12-14
DCK12000-10-13
DHR11999-06-09
CGZ11997-06-16
JHW11994-11-21
DNN11988-08-04
JIY11987-01-21
JFH11986-12-16
CHJ11985-08-21
CIX11982-09-14
CIC11982-09-14
CFJ11981-12-31