STS CORPORATION

FDA Device Registration & Listing · Duluth, GA, US · Registration 3014150341

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014150341
FEI Number
3014150341
Entity Name
STS CORPORATION
City/State/Country
Duluth, GA, US
Establishment Address
3500 Duluth Park LN, Suite 420, Duluth, GA 30096, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device
Owner / Operator
STS Corporation (Owner Number: 10056102)
Owner / Operator Contact Address
3500 Duluth Park LN, Suite 420, Duluth, GA 30096, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

STSC, General, Calibrator for Hemoglobin and Hematocrit Measurement BioDigit, Leptospira IgG/IgM, Antigens, All, Leptospira Spp. BioDigit, Indicator Method, Urinary Protein or albumin (Non-Quantitative) Test System STSC, General, Plasma, Coagulation Control Asan Pharm Manufactured, GNX 1, BioDigit, Influenza A/B, Antigens, Cf (Including Cf Control), Influenza Virus A, B, C STSC, General, Calibrator for Platelet Counting Water Purifier STSC, GAP, Water Purifier BioMed Lab, Tech, G&W, NEO Splint Exo-I, PPM-1, Passive Exosome Isolation (SEC Columns and Buffers), EXoPERT Enerskin E75 Compression Wrap, Foot Wrap for Treating Restless Leg Syndrome Symptoms BioDigit, Mycoplasma Ag., Antigens, Cf, All, Mycoplasma Spp. (Mycoplasma Spp. Serological Reagents) Syringe, Cartridge, Dental - AMTC-K - EJI 2 STSC, Fluorometer STSC, General, Prothrombin-Proconvertin and Thrombotest BioDigit, Morphine Test System, Test, Morphine, Employment and Insurance Testing BioMed Lab Tech, NEO Cast Needle, Aspiration and Injection, Disposable - AMTC & GAP, GAA, 1 STSC, General, Plasma, Control, Normal STSC, General, Plasma, Fibrinogen Control STSC, General, Control, Red-Cell Qbiosens Qcsl Cell Separation and Lysis Device STSC, General, Control Material Blood Circulating Epithelial Cancer Cell BioDigit, Anti-Tsutsugamushi, Antiserum, Typhus Fever (Rickettsia Serological Reagents) STSC, GAP, Disinfectant, Subsystem, Water Purification System STSC, GAP, Processor, Radiographic-Film, Automatic STSC, General, Calibrator for Cell Indices Enerskin E75 Compression Sleeve, Legging, Compression, Non-Inflatable Asan Pharm Manufactured, BioDigit, KDW 1, Container, Specimen Mailer and Storage, Temperature Controlled, Sterile BioDigit, Benzodiazepine Test System, Test, Benzodiazepine, Employment And Insurance Testing STSC, General, Standards and Controls, Hemoglobin, Normal and Abnormal Asan Viral Transport Media, Non-Progating Transport, JSM Culture Media, Non-Propagating Transport - Asan Viral Transport Media, Asan Pharmaceutical, BioDigit, JSM, 1 STSC, GAP, Purifier, Water, Ultraviolet, Medical AMTC-K & JW KF-94, MFKMT, LYU 1, Accessory, Surgical Apparel, Face Mask ARM Dx, JJE-1, Raman Spectroscopy Analyzer for Exosome Signal Measurement, EXoPERT Qbiosens Qcsl Cell Separation and Lysis Device STSC, General, Hematocrit, Tube, Rack, Sealer, Holder BioDigit, Rotavirus, Enzyme Linked Immunoabsorbent Assay, Rotavirus Enerskin E75 Compression Sleeve, Stocking, Medical Support (To Prevent Pooling of Blood in Legs) BioDigit, Adenovirus, Antigens, Cf (Including Cf Control), Adenovirus 1-33 Asan Viral Transport Media, Notified Per the VTM Guidance, QCM Transport Medium, Notified Per the VTM Guidance - Asan Viral Transport Media, Asan Pharmaceutical, BioDigit, QMC, 1 STSC, General, Automated Pipetting, Diluting and Specimen Processing Workstations for Flow Cytometric Analysis STSC, General, Control Hemoglobin BioDigit, Anti-HBs, Kit, Serological, Positive Control BioDigit, HAV IgG/IgM, Multi-Analyte Controls, All Kinds (Assayed) Qbiosens Qcsl Cell Separation and Lysis Device Syringe, Restorative Impression Material - AMTC-K - EID 1, Dental Hand Instrument BioDigit, Strep A, Antigens, All Groups, Streptococcus Spp. Qbiosens Qcsl Cell Separation and Lysis Device BioDigit, Albumin, Antigen, Antiserum, Control - Albumin Immunological Test System Qbiosens Qcsl Cell Separation and Lysis Device Qbiosens Qcsl Cell Separation and Lysis Device Asan Pharmaceutical Manufactured, BioDigit, KXG 1, Applicator, Absorbent Tipped, Sterile Biopsy Needle Guide Kit - AMTC & GAP, OIJ, 2 STSC, GAP, Programmer, Changer, Film/Cassette, Radiographic Enerskin E75 Compression Stocking, Medical Support (For General Medical Purposes) BioDigit, Barbiturate Test System, Test, Barbiturate, Employment And Insurance Testing Qbiosens Qcsl Cell Separation and Lysis Device ExoTractor, KZR-1, Automated Exosome Isolation Instrument (Uses Exo-i), EXoPERT Qbiosens Qcsl Cell Separation and Lysis Device BioDigit, Cocaine and Cocaine Metabolite Test System, Test, Cocaine And Cocaine Metabolite, Employment & Insurance Test Syringe, Periodontic, Endodontic, Irrigating - AMTC-K - EIC 1, Dental Hand Instrument Qbiosens Qpre Foodborne Virus Detection Device STSC, General, Control, Plasma, Abnormal Enerskin E75® Compression Apparel BioDigit, Anti-Syphilis, Single (Specified) Analyte Controls (Assayed And Unassayed) Qbiosens Qcsl Cell Separation and Lysis Device Asan Pharmaceutical Manufactured, BioDigit, NNL 1, Container, Specimen Mailer and Transport/Storage, Temperature Control STSC, GAP, Processor, Radiographic-Film, Automatic Device, Bleeding Time, Hematology - AMTC & GAP, JCA, 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology Class 2 864.8165 2017-12-11
GRY Antigens, All, Leptospira Spp. Microbiology Class 2 866.3350 2019-02-13
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2019-02-26
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2017-12-11
GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C Microbiology Class 1 866.3330 2019-02-13
KRY Calibrator For Platelet Counting Hematology Class 2 864.8175 2017-12-11
JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) Clinical Chemistry Class 1 862.2050 2018-11-02
NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery Class 1 878.3910 2017-11-10
PPM General Purpose Reagent Pathology Class 1 864.4010 2026-02-24
OTX Foot Wrap For Treating Restless Leg Syndrome Symptoms Physical Medicine Class 1 890.5760 2017-11-07
GSB Antigens, Cf, All, Mycoplasma Spp. Microbiology Class 1 866.3375 2019-02-14
EJI Syringe, Cartridge Dental Class 2 872.6770 2021-08-04
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2018-11-02
JPF Prothrombin-Proconvertin And Thrombotest Hematology Class 2 864.7735 2017-12-11
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2019-02-13
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2017-11-10
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2018-11-02
GIZ Plasma, Control, Normal Hematology Class 2 864.5425 2017-12-11
GIL Plasma, Fibrinogen Control Hematology Class 2 864.7340 2017-12-11
GJR Control, Red-Cell Hematology Class 2 864.8625 2017-12-11
NZB Quality Control Material, Genetics, Dna Microbiology Class 2 866.5910 2017-12-11
NRS Control Material, Blood Circulating Epithelial Cancer Cell Hematology Class 2 864.8625 2017-11-14
GPN Antiserum, Typhus Fever Microbiology Class 1 866.3500 2019-02-14
NIH Disinfectant, Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2018-11-02
EGY Processor, Radiographic-Film, Automatic, Dental Radiology Class 2 892.1900 2018-11-02
KRX Calibrator For Cell Indices Hematology Class 2 864.8150 2017-12-11
LLK Legging, Compression, Non-Inflatable General Hospital Class 2 880.5780 2017-11-14
KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile Pathology Class 1 864.3250 2020-03-30
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2019-02-13
GFS Standards And Controls, Hemoglobin, Normal And Abnormal Hematology Class 2 864.8625 2017-12-11
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2021-02-24
KMG Purifier, Water, Ultraviolet, Medical General Hospital Class 2 880.6710 2018-11-02
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-06-21
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2026-02-24
GGL Control, White-Cell Hematology Class 2 864.8625 2017-12-11
GHY Hematocrit, Tube, Rack, Sealer, Holder Hematology Class 2 864.6400 2017-12-11
LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus Microbiology Class 1 866.3405 2019-02-13
DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) General Hospital Class 2 880.5780 2017-11-07
GOD Antigens, Cf (Including Cf Control), Adenovirus 1-33 Microbiology Class 1 866.3020 2019-02-13
QMC Transport Medium, Notified Per The Vtm Guidance Microbiology Class 1 866.2390 2021-02-24
PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis Clinical Chemistry Class 1 862.2750 2017-11-30
GGM Control, Hemoglobin Hematology Class 2 864.8625 2017-12-11
MJX Kit, Serological, Positive Control Clinical Chemistry Class 1 862.1660 2019-02-13
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2019-02-13
KSA Calibrator For Red-Cell And White-Cell Counting Hematology Class 2 864.8185 2017-12-11
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2021-08-04
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2019-02-13
GKG Centrifuge, Hematocrit Hematology Class 2 864.6400 2017-12-11
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2019-02-26
GGJ Fluid, Diluting, White-Cell Hematology Class 1 864.8200 2017-11-14
PCA Dna Genetic Analyzer Clinical Chemistry Class 2 862.2570 2017-12-11
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-06-11
OIJ Biopsy Needle Guide Kit Radiology Class 2 892.1560 2018-11-02
IZP Programmer, Changer, Film/Cassette, Radiographic Radiology Class 2 892.1870 2018-11-02
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2017-11-06
PUY Test, Barbiturate, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3150 2019-02-13
GHO Hemocytometer Hematology Class 1 864.6160 2017-11-14
KZR Chromatography (Liquid, Gel), Clinical Use Clinical Chemistry Class 1 862.2260 2026-02-24
GKH Apparatus, Automated Blood Cell Diluting Hematology Class 1 864.5240 2017-11-14
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2019-02-13
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2021-08-04
OUC Norovirus Serological Reagent Microbiology Class 2 866.3395 2017-12-11
GGC Control, Plasma, Abnormal Hematology Class 2 864.5425 2017-12-11
MHW Dressing, Compression General Hospital Class 1 880.5075 2018-02-16
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2019-02-13
PFF High Throughput Dna Sequence Analyzer Immunology Class 2 862.2265 2017-12-11
NNL Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile Pathology Class 1 864.3250 2020-03-30
IXW Processor, Radiographic-Film, Automatic Radiology Class 2 892.1900 2018-11-02
JCA Device, Bleeding Time Hematology Class 2 864.6100 2018-11-02

Official Correspondent

Rick Yi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STS Corporation
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
K052101 Roche Diagnostics C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C 2005-08-26
K885053 Biotrol, USA, Inc. BIOTROL URINE PROTEINS REAGENT 1989-01-30
K021022 Instrumentation Laboratory CO HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14
K113211 Instrumentation Laboratory CO HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04
K082859 Instrumentation Laboratory CO HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED 2008-12-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014150341. Last updated year: 2026. Please use registration number 3014150341 when referencing this establishment in official correspondence.
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