FDA.reportPublic FDA data

MERCEDES MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10638511000442352MERCEDES MEDICAL LLC1Y2026-01-0112210 Rangeland Parkway Lakewood Ranch FL US 34211

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850011007143Tanner Scientific® - Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase8003312716sherry.harris@mercedesmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
546281952478671K994200ACCESS HYBRITECH PSA QC, MODEL 37209JJX2000-01-18
546281893444373K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCEC1998-07-14
546281390954748K971849CYTOLOGY BRUSHHHT1997-07-24
546281012379566K931939OLYMPUS CREATININE REAGENTCGX1993-09-21
546281545396010K925603OLYMPUS CHOLESTEROL REAGENTCHH1993-02-08
546281408978541K925339OLYLMPUS ALANINE AMINOTRANSFERASE REAGENTCKA1993-02-05
546281080190881K925338OLYMPUS CHLORIDE REAGENTCHJ1992-12-11
546282005706840K925155OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENTCIT1993-01-26
546281534840977K924965OLYMPUS LACTATE DEHYDROGENASE REAGENTCFJ1992-11-16
546281198725146K924691OLYMPUS IRON REAGENTJIY1992-12-18
546281326826532K924601OLYMPUS GLUCOSE REAGENTCFR1992-12-03
546281183942648K924368OLYMPUS ALBUMIN REAGENTCIX1993-02-08
546281883853565K922597OLYMPUS UREA NITROGEN (BUN) REAGENTCDQ1992-07-10
546281930111420K922361OLYMPUS TOTAL PROTEIN REAGENTCEK1992-07-16
546281811575355K922229OLYMPUS TRIGLYCERIDE REAGENTCDT1992-07-02
546281715167132K921806VACUTAINER(R) BRAND SST(R) AND CAT TUBESJKA1992-04-29
546281402539196K233417AllTest Fentanyl Urine Test CassetteNGL2023-10-26
546282047126791K220900Safety Blood Collection Needles with/without Needle HolderJKA2022-08-10
546281142595126K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)FMI2022-04-12
546281326462305K212535Nitrile Powder Free Blue Examination Gloves, Non-SterileLZA2021-12-04
546281175661705K202188Safety Blood Collection Sets for Single UseJKA2021-02-19
546281300025486K192681Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)FPA2020-07-28
546281161580994K183287Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2019-04-05
546281186152667K170397Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy DrugsLZA2017-07-10
546281012491065K163093Safety Blood Collection SetFMI2017-03-14
546281154541054K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsJLW2016-08-18
546281162285623K142373Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. SystMRG2014-12-22
546282061893526K131811UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSDKZ2013-07-19
546281963761077K110981
546281241778667K052082FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020JMG2005-08-19
546281301649912K050057COULTER LH 750 HEMATOLOGY ANALYZERGKZ2005-02-10
546281069541307K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024JIT2004-03-10
546281034157061K021475BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SETFMI2002-07-19
546281545360373K001935ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565CDZ2000-08-22
546281450478956K000369VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDERFMI2000-03-30
546281001077733
546281023483679
546281030771009
546281066982177
546281092570349
546281149811417
546281160230288
546281176827027
546281191583377
546281196261371
546281200102440
546281236176371
546281255150146
546281277090816
546281332149775
546281337580797
546281342446637
546281379547788
546281389501651
546281459457074
546281478351715
546281482764571
546281492704510
546281496134643
546281519814347
546281528110677
546281532209469
546281532974277
546281548947027
546281597694871
546281671638276
546281700273737
546281729641945
546281764710869
546281808472270
546281809326822
546281878946297
546281911610480
546281999346118
546282028708856
546282043736932
546282070046361

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI42022-04-12
JKA32022-08-10
LZA32021-12-04
NGL12023-10-26
FPA12020-07-28
JLW12016-08-18
MRG12014-12-22
DKZ12013-07-19
JMG12005-08-19
GKZ12005-02-10
JIT12004-03-10
CDZ12000-08-22
JJX12000-01-18
CEC11998-07-14
HHT11997-07-24
CGX11993-09-21
CHH11993-02-08
CIX11993-02-08
CKA11993-02-05
CIT11993-01-26
JIY11992-12-18
CHJ11992-12-11
CFR11992-12-03
CFJ11992-11-16
CEK11992-07-16
CDQ11992-07-10
CDT11992-07-02

GUDID#

46 records. Showing 1-40. Next