FDA.reportPublic FDA data

Misty McWhorter-Darley

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041920653004192065Misty McWhorter-Darley1N2026-01-0112210 Rangeland Pkwy Lakewood Ranch FL US 34211

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
650661299001659P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSAMTF1991-09-25
650661970909161K994200ACCESS HYBRITECH PSA QC, MODEL 37209JJX2000-01-18
650661448334703K992257NEW MULTIPLES REAGENT STRIPSJIR1999-11-24
650661314675583K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCEC1998-07-14
650661817393794K980987BECTON DICKINSON SYRINGEFMF1998-06-11
650661705182857K973966ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCDP1997-10-31
650662062628184K972706CLINITEK MICROALBUMIN REAGENT STRIPSCJG1997-09-09
650661440248303K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)CHP1997-02-25
650662070779768K960913ACCESS FREE T3 ASSAYCDP1996-03-29
650661686707308K955769ACCESS PROGESTERONE ASSAYJLS1996-02-05
650661213605749K955436ACCESS VITAMIN B12 ASSAY (MODIFICATION)CDD1996-01-24
650661909962294K954680ACCESS PROLACTIN ASSAY (MODIFICATION)CFT1995-10-20
650661450063825K952148AXSYM ULTRASENSITIVE HTSH IIJLW1995-06-29
650661586513965K946173STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKGAQ1995-01-09
650661452695481K946067TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANELCHH1995-02-22
650661095460909K940005ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAYCGJ1994-03-03
650661720721744K934764VIDAS T3 ASSAYCDP1994-03-22
650661211453066K931939OLYMPUS CREATININE REAGENTCGX1993-09-21
650661190892928K930984ACCESS(R) TOTAL IGE ASSAYDGC1993-06-09
650661610486389K930010ACCESS THYROID UPTAKE ASSAYCEE1993-06-07
650661529433459K926393VIDAS THYROXINE (T4) ASSAY (T4)KLI1993-05-13
650661996388339K925802ACCESS DIGOXIN ASSAYKXT1993-01-13
650661135873494K925603OLYMPUS CHOLESTEROL REAGENTCHH1993-02-08
650661369283286K925338OLYMPUS CHLORIDE REAGENTCHJ1992-12-11
650661345340885K925337OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENTJQB1993-01-26
650661921198931K924691OLYMPUS IRON REAGENTJIY1992-12-18
650661407958184K924659OLYUMPUS TOTAL PROTEIN REAGENTCEK1992-12-29
650661756132361K924601OLYMPUS GLUCOSE REAGENTCFR1992-12-03
650661634262079K922369OLYMPUS ALBUMIN REAGENTCIX1992-07-17
650661851288681K922361OLYMPUS TOTAL PROTEIN REAGENTCEK1992-07-16
650661908692392K914469CHOLESTECH LIPID MONIT SYST, TOTAL CHOL/TRIG PANELCHH1991-10-30
650661228370310K240479Access OV MonitorLTK2024-05-10
650661726953730K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsJLW2016-08-18
650661420117037K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerLCP2015-09-25
650661755367684K141374BICARBONATE CALIBRATORJIT2014-06-30
650661862886854K133356PROLENE POLYPROPYLENE NONABSORBABLE SUTUREGAW2013-12-06
650661452124989K130020ACCESS TOTAL BHCG (5TH IS)DHA2013-10-01
650661815211980K112933ACCESS THYROGLOBULIN ANITBODYJNL2011-12-27
650661903646091K110771BD SINGLE USE, HYPODERMIC SYRINGEFMF2011-05-13
650661021258637K060774FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208CGN2006-04-21
650661295397080K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020JMG2005-08-19
650661260338950K051787TRIAGE BNP TEST, MODEL 98000XRNBC2005-09-22
650662027250036K042890TRIAGE D-DIMER TEST, MODEL 98100GHH2004-11-29
650661894571278K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024JIT2004-03-10
650661145827728K031899QUICKVUE INFLUENZA A+B TESTPSZ2003-09-11
650661472367396K023093ACCESS HYPERSENSITIVE HTSH ASSAYJLW2002-11-25
650661747585001K022269COATED VICRYL* (POLYGLACTIN 910) SUTUREGAM2002-09-13
650661011796110K020679INRATIOGJS2002-05-06
650661372158230K010550VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428LTJ2001-04-24
650661236661750K010188BD ECLIPSE HYPODERMIC NEEDLEFMI2001-03-01
650661639990098K001935ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565CDZ2000-08-22
650661434756196K000716ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZERJHX2000-03-20
650661480331193
650661784433795
650662027341465

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JLW32016-08-18
CDP31997-10-31
CHH31995-02-22
JIT22014-06-30
FMF22011-05-13
CEK21992-12-29
LTK12024-05-10
LCP12015-09-25
GAW12013-12-06
DHA12013-10-01
JNL12011-12-27
CGN12006-04-21
NBC12005-09-22
JMG12005-08-19
GHH12004-11-29
PSZ12003-09-11
GAM12002-09-13
GJS12002-05-06
LTJ12001-04-24
FMI12001-03-01
CDZ12000-08-22
JHX12000-03-20
JJX12000-01-18
JIR11999-11-24
CEC11998-07-14
CJG11997-09-09
CHP11997-02-25
JLS11996-02-05
CDD11996-01-24
CFT11995-10-20
GAQ11995-01-09
CGJ11994-03-03
CGX11993-09-21
DGC11993-06-09
CEE11993-06-07
KLI11993-05-13
JQB11993-01-26
KXT11993-01-13
JIY11992-12-18
CHJ11992-12-11