Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013660430

FEI Number

3013660430

Entity Name

High Technology, Inc.

City/State/Country

North Attleboro, MA, US

Establishment Address

20 Alice Agnew Dr, North Attleboro, MA 02763, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

High Technology, Inc. (Owner Number: 10035029)

Owner / Operator Contact Address

20 Alice Agnew Dr., Attleboro Falls, MA 02763, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Microalbumin Standard Set Microalbumin Calibrator Set Low-density lipoprotein (LDL) Reagent Set Potassium Reagent Set Bilirubin Direct (semi-auto) Reagent Set Bilirubin Total (semi-auto) Reagent Set Bilirubin Direct (auto) Reagent Set Bilirubin Total (auto) Reagent Set High-density lipoprotein (HDL) Reagent Set Lactate dehydrogenase (LDH-L) Reagent Set Power Spin MX Power Spin FX Power Spin BX Power Spin LX HTI PowerSpin HX Centrifuge HTI PowerSpin Series Centrifuge HTI PowerSpin VX Centrifuge HTI PowerSpin MX Centrifuge HTI PowerSpin FX Centrifuge HTI PowerSpin LX Centrifuge MicroCC-20 Plus MicroCC-20 Vet MicroCC-25 Plus Chemistry Multi-Calibrator Set Total Protein Reagent Set Microprotein Reagent Set Hemoglobin Reagent Set HT-Coag D-Dimer Reagent Kit HTI Sheath Focusing Solution Gamma-glutamyl transferase (GGT) Reagent Set HTI SA-18 HTI Detergent HTI Detergent Drypack Glucose Oxidase Reagent Set HT-Coag PT Reagent kit Lactate Reagent Set HTI ImmunoChem-2600 HTI ImmunoChem-2600 Plus HTI ImmunoChem-2200 HTI ImmunoChem-2200 Plus ImmunoChem 2600 ImmunoChem 2200 Chemistry Control Set Microalbumin Control Set Creatine Kinase-MB Control Set Ammonia/Alcohol Control Set Linearity Control Material HTI Urine Control Kit HTI Control kit HTI BioChem-Check Kit Glucose Hexokinase Reagent Set HTI IV-Series Microscope HT-Coag Fibrinogen Reference Plasma Reagent kit HT-Coag Fibrinogen Assay kit HT-Coag Thrombin Reagent kit (for Fib Assay) HT-Coag D-Dimer Calibrator HTI CL-50 Plus Urine Analyzer CL-500 CL-50 Plus HTI CL-50 Urine Analyzer HTI Urine Analyzer HTI CL-500 Urine Analyzer Direct HDL/LDL Control Set Lipid Control Set Acid Phosphatase Reagent Set Sodium (auto) Reagent Set Sodium (semi-auto) Reagent Set HTI H-Series Microscope HTI IP-Series Microscope HTI M-Series Microscope HTI G-Series Microscope HTI Z-Series Microscope Fructosamine Control Set Precision Test Fluid P150 & P250 HT-Coag APTT Reagent kit Creatine Kinase-MB Reagent Set Creatine Kinase (CK) Reagent Set Urea Nitrogen (BUN) Reagent Set Glycohemoglobin Control Set Fructosamine Reagent Set Glycohemoglobin Reagent Set Hemoglobin A1c Control Set Glycosylated hemoglobin (HbA1c) Reagent Set Hemoglobin A1c (HbA1c) Control Set Hemoglobin A1c (HbA1c) Standard Set Hemoglobin A1c (HbA1c) Reagent Set Hemoglobin A1c (HbA1c) Calibrator Set Creatinine Reagent Set HT-Coag Control 3 Reagent kit HT-Coag Calibration Plasma Reagent kit HT-Coag Control 2 Reagent kit HT-Coag Multicalibrator Reagent kit HT-Coag Control 1 Reagent kit HT-Coag D-Dimer Control Alkaline Phosphatase Reagent Set HTI Lytic Reagent Albumin Reagent Set Hemoglobin Control Set Lipase Reagent Set ALT, Alanine aminotransferase (GPT), Reagent Set Alanine Aminotransferase (ALT or SGPT) Reagent Set Chloride Reagent Set Phosphorus Reagent Set Microalbumin Reagent Set Amylase Reagent Set Magnesium Reagent Set HTI Enzymatic Cleaner HTI Cleaning Solution Washing Solution (Activation) Washing Solution (De-proteinizer) Refill Solution for ISE Electrodes Reagent Pack (Calibrant A, Calibrant B) HTI Enzymatic Cleaner Concentrate Refill Solution for Reference Electrode Washing Solution (Cleaning) Washing Solution Cleaning Solution HTI Enzymatic Cleaner Drypack Shutdown Pack HT-Coag Calcium Chloride Reagent Kit HT-Coag Imidazole Buffered Saline Reagent Kit Urine Dilute Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-08-08
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2013-08-08
CEJ	Tetraphenyl Borate, Colorimetry, Potassium	Clinical Chemistry	Class 2	862.1600	2013-08-08
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2013-08-07
LBR	Ldl & Vldl Precipitation, Hdl	Clinical Chemistry	Class 1	862.1475	2013-08-08
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2013-08-08
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	2011-08-12
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2020-03-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-08-08
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2013-08-08
KHG	Whole Blood Hemoglobin Determination	Hematology	Class 2	864.7500	2013-08-08
GHH	Fibrin Split Products	Hematology	Class 2	864.7320	2013-08-07
KIP	Formulations, Balanced Salt Solutions	Hematology	Class 1	864.2875	2013-08-08
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2013-08-08
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-01-27
JCB	Detergent	Pathology	Class 1	864.4010	2013-08-08
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-08-08
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2013-08-07
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2013-08-08
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2011-01-27
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-08-07
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2013-08-08
IBL	Microscope, Inverted Stage, Tissue Culture	Pathology	Class 1	864.3600	2011-08-12
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2013-08-07
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2011-01-27
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-08-08
JFH	Acid Phosphatase (Prostatic), Tartrate Inhibited	Clinical Chemistry	Class 2	862.1020	2013-08-07
CEI	Uranyl Acetate/Zinc Acetate, Sodium	Clinical Chemistry	Class 2	862.1665	2013-08-08
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2011-08-12
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-08-08
GFO	Activated Partial Thromboplastin	Hematology	Class 2	864.7925	2013-08-07
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2013-08-08
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2013-08-08
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-08-08
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-08-08
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2013-08-07
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2013-08-07
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	2013-08-08
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2013-08-07
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2015-03-27
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2013-08-08
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2013-08-07
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2013-08-08
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2013-08-08
DDZ	Albumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2013-08-08
CIJ	Saccharogenic, Amylase	Clinical Chemistry	Class 2	862.1070	2013-08-07
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2013-08-08
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2013-08-08

Official Correspondent

Gary Titov

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

High Technology, 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
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16
K103548	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491	2011-06-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
Z-0102-2021	Siemens Healthcare Diagnostics, Inc.	2	Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 11097637

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2122870	BECKMAN COULTER, INC.	CHASKA, MN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013660430. Last updated year: 2026. Please use registration number 3013660430 when referencing this establishment in official correspondence.