Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2435505

FEI Number

1000119795

Entity Name

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.

City/State/Country

CORTLANDT MANOR, NY, US

Establishment Address

510 FURNACE DOCK RD., CORTLANDT MANOR, NY 10567, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

POLYMEDCO, INC. (Owner Number: 9001475)

Owner / Operator Contact Address

510 FURNACE DOCK RD., --, Cortlandt Manor, NY 10567, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K924061

PMA Number

N/A

All Registered Proprietary Names

OC-Light S FIT PATHFAST NTproBNP OC-Light iFOB Test OC-Auto Micro 80 iFOB Test System PATHFAST CK-MB-II OC-Auto SENSOR io IFOB Test PATHFAST cTnI-II Poly stat Strep A Flip Test Epi proColon PolyStat H. pylori Poly stat FLU A&B Test Pipette Tip PATHFAST hs-cTnI-II (High Sensitive Troponin) Sediten ESR System Poly stat Strep A Strip Test BTA stat Test Kit PolyStat Mono PolyStat hCG Cancer Antigen Control

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2015-08-26
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2017-06-27
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2009-07-09
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2009-07-09
JHE	Radioassay, 17-Hydroxycorticosteroids	Clinical Chemistry	Class 1	862.1385	2017-06-27
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2020-06-12
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2017-06-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-06-27
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2009-07-09
PHP	System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection	Unknown	Class 3	N/A	2017-05-10
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2009-07-09
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2015-02-13
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2017-08-11
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2024-04-19
JPH	Test, Erythrocyte Sedimentation Rate	Hematology	Class 1	864.6700	2009-07-10
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2018-06-14
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Immunology	Class 2	866.6010	2008-02-01
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2009-07-09
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2009-07-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-07-09

Official Correspondent

Todd Kelley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

POLYMEDCO, 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
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14
K171566	Siemens Healthcare Diagnostics, Inc.	Atellica IM High-Sensitivity Troponin I (TNIH)	2018-07-19
K182225	Siemens Healthcare Diagnostics, Inc.	Dimension Vista High-Sensitivity Troponin I (TNIH) Assay	2019-03-04
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2022	Beckman Coulter Inc.	2	Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Z-0052-2021	Siemens Healthcare Diagnostics, Inc.	2	Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
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.

Similar Registrations

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1618982	HELENA LABORATORIES, CORP.	BEAUMONT, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2435505. Last updated year: 2026. Please use registration number 2435505 when referencing this establishment in official correspondence.