Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009518015

FEI Number

3009518015

Entity Name

7051395 CANADA INC DBA HTA DIRECT SOURCING

City/State/Country

Champlain, NY, US

Establishment Address

102 West Service Road, Unit 047, Champlain, NY 12919, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

7051395 Canada Inc Dba HTA Direct Sourcing (Owner Number: 10084602)

Owner / Operator Contact Address

102 West Service Road, Unit 1047, Champlain, NY 12919, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K020608

PMA Number

N/A

All Registered Proprietary Names

Trial Frame Single (specified) analyte controls (assayed and unassayed) Calibrator, secondary 3014233026 Foreign Exporter RADIOASSAY, INTRINSIC FACTOR BLOCKING ANTIBODY Lenses, soft contact, daily wear Lens, contact, (disposable) NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) PAD, EYE RADIOIMMUNOASSAY, ESTRADIOL Calibrator, primary 100566RADIOIMMUNOASSAY, FREE THYROXINE Calibrator, primary Phoropter Lenses, soft contact, daily wear Lens, contact, (disposable) Lenses, soft contact, daily wear TAPE AND BANDAGE, ADHESIVE Lens, contact, (disposable) Lenses, soft contact, daily wear Lenses, soft contact, daily wear Set, administration, intravascular Tubes, vials, systems, serum separators, blood collection Lenses, soft contact, daily wear Lenses, soft contact, daily wear Lens, contact, (disposable) Instrument Tip Protectors Lenses, soft contact, extended wear PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED Lens, contact, (disposable) Lenses, soft contact, daily wear Lens, contact, (disposable) Lenses, soft contact, daily wear Lenses, soft contact, daily wear Lens, contact, (disposable) Calibrator, primary Enzyme immunoassay, non-radiolabeled, total thyroxine Calibrator, secondary Radioimmunoassay (two-site solid phase), ferritin Lens, contact, (disposable) Radioassay, vitamin b12 ACID, FOLIC, RADIOIMMUNOASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE),FOR CLINICAL USE Ferritin, antigen, antiserum, control ens, contact, (disposable) 3014233026 Foreign Exporter Lenses, soft contact, daily wear Lenses, soft contact, extended wear Prism Bar MASK, SCAVENGING Lenses, soft contact, extended wear PAD, ALCOHOL, DEVICE DISINFECTANT TRIAL LENS SET SYSTEM, TEST, VITAMIN D Calibrator, secondary Lenses, soft contact, daily wear Lens, contact, (disposable) Post Mydriatic Eyewear Calibrator, secondary RADIOIMMUNOASSAY, PARATHYROID HORMONE Lenses, soft contact, daily wear Lenses, soft contact, extended wear Lenses, soft contact, daily wear Lens, contact, (disposable) Lenses, soft contact, daily wear Set, administration, intravascular Lenses, soft contact, daily wear Lens, contact, (disposable) Tube tracheostomy and tube cuff Lenses, soft contact, daily wear

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2024-05-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-12-19
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	Class 2	862.1810	2024-12-19
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2024-12-19
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2025-09-24
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2024-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-12-19
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-12-19
HKN	Refractor, Manual, Non-Powered, Including Phoropter	Ophthalmic	Class 1	886.1770	2024-05-16
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-04-05
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2024-12-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-09-05
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2024-12-19
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-12-19
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2024-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-12-19
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-12-19
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2024-12-19
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2024-12-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-12-19
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2024-12-19
HKW	Prism, Bar, Ophthalmic	Ophthalmic	Class 1	886.1650	2024-05-16
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2024-12-19
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2024-12-19
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2023-12-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-12-19
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-06-28
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2024-12-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	Class 2	868.5800	2024-12-19
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2024-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

7051395 Canada Inc Dba HTA Direct Sourcing

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009518015. Last updated year: 2026. Please use registration number 3009518015 when referencing this establishment in official correspondence.