Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1036362

FEI Number

1036362

Entity Name

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC.

City/State/Country

Doral, FL, US

Establishment Address

7245 N.W. 43RD ST., Doral, FL 33166, US

Establishment Type(s)

Remanufacture Medical Device,Repack or Relabel Medical Device

Owner / Operator

SST International Inc. (Owner Number: 1036362)

Owner / Operator Contact Address

7245 N.W. 43RD ST., --, Miami, FL 33166, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973550

PMA Number

N/A

All Registered Proprietary Names

Mindray Sterilizer, steam Bio-Chem Sterilizer, steam EXCELSIOR AS TISSUE PROCESSOR Clinitek Analyzer ACT 5 DIFF Immulite Analyzer Clinitek Analyzer Easylyte Analyzer Envoy Analyzer EON Analyzer Sterilizer, steam

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-06-20
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2018-06-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-06-20
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2018-06-19
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2018-10-04
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2018-06-20
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2018-06-20
NFZ	Test, Creatinine, Over The Counter	Clinical Chemistry	Class 2	862.1225	2018-06-20
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-06-26
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2018-06-20
JHR	Radioimmunoassay, Immunoglobulins (D, E)	Immunology	Class 2	866.5510	2018-06-20
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2018-06-20
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2018-06-20
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2018-06-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-06-20
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2018-06-20
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2018-06-20
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2018-06-20
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2018-06-20
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2018-06-20
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2018-06-20
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2018-06-20
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2018-06-20
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2018-06-20
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2018-06-20
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2018-06-20
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2018-06-20
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2018-06-20
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-06-20
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2018-06-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-06-20
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-06-20
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-06-20
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2018-06-20
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-06-20
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2018-06-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-06-20
CHL	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	Clinical Chemistry	Class 2	862.1120	2018-06-20
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2018-06-20
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-06-20
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2018-06-20
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2018-06-20
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2018-06-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2018-06-20
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2018-06-20
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2018-06-20
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2018-06-20
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2018-06-20
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2018-06-20
FLE	Sterilizer, Steam	General Hospital	Class 2	880.6880	2018-06-19

Official Correspondent

PETER LUE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SST International Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K021223	Sauter AG	BELIMED STEAM STERILIZER, MODEL TOP 5000	2002-06-26
K050263	M.O. Com S.R.L.	MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU	2006-11-21
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1036362. Last updated year: 2026. Please use registration number 1036362 when referencing this establishment in official correspondence.