Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1317202

FEI Number

1317202

Entity Name

TESSY PLASTICS CORP.

City/State/Country

ELBRIDGE, NY, US

Establishment Address

488 ROUTE 5 WEST, ELBRIDGE, NY 13060, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TESSY PLASTICS CORP. (Owner Number: 1317202)

Owner / Operator Contact Address

488 ROUTE 5 WEST, --, Elbridge, NY 13060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-06-18
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-06-18
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2024-06-18
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2024-06-18
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-06-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2024-06-18
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2024-06-18
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2020-12-28
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-12-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-12-20
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2024-12-20
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2012-12-03
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2022-01-04
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2022-01-04
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2019-03-21
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2026-03-30
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2025-04-22
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2012-11-28

Official Correspondent

ERIKA FIELD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TESSY PLASTICS CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012806810	Tessy Plastics Corp.	Skaneateles, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25
K151792	Siemens Healthcare Diagnostics, Inc.	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	2015-11-20
K141999	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR TSH	2015-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0042-2020	Roche Diagnostics Operations, Inc.	2	Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Z-0043-2020	Roche Diagnostics Operations, Inc.	2	Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502

Similar Registrations

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3016438761	ABBOTT LABORATORIES	Irving, TX, US
2517506	SIEMENS HEALTHCARE DIAGNOSTICS INC.	NEWARK, DE, US
3006198300	Diamond Diagnostics Inc.	Budapest, HU
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1317202. Last updated year: 2026. Please use registration number 1317202 when referencing this establishment in official correspondence.