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Data / Medical devices / United States / Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC.

Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC.: FDA-registered device maker in Cortlandt Manor, NY, United States, 20 510(k) clearances and 1 PMA approval

Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC. is registered with the FDA (registration 2435505) in Cortlandt Manor, NY, United States. It lists 23 device types. The FDA files 20 510(k) clearances and 1 PMA approval under its listings, the newest dated March 20, 2024. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC.
FDA registration number
2435505
FEI number
1000119795
Address
510 Furnace Dock RD., Cortlandt Manor, NY, United States, 10567
Owner or operator
POLYMEDCO, INC. (9001475)
Roles
Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
February 1, 2008
Registered through
2026
Brand names listed
BTA, BTA stat Test Kit, Cancer Antigen Control, Epi proColon, OC-Auto Micro 80 iFOB Test System, OC-Auto SENSOR DIANA iFOB Test System, OC-Auto SENSOR io IFOB Test, OC-Light S FIT and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Complaint file establishmentaccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Repackager or relabeleraccessdata.fda.gov
Automated Occult Blood AnalyzerOOX2Repackager or relabeleraccessdata.fda.gov
Calibrator, SecondaryJIT2Complaint file establishmentaccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Repackager or relabeleraccessdata.fda.gov
Fibrin Split ProductsGHH2Complaint file establishmentaccessdata.fda.gov
Fluorometric Method, Cpk Or IsoenzymesJHX2Complaint file establishmentaccessdata.fda.gov
Helicobacter PyloriLYR1Repackager or relabeleraccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Complaint file establishmentaccessdata.fda.gov
Micro PipetteJRC1Complaint file establishmentaccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Repackager or relabeleraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Complaint file establishmentaccessdata.fda.gov
Radioassay, 17-HydroxycorticosteroidsJHE1Complaint file establishmentaccessdata.fda.gov
Reagent, Occult BloodKHE2Repackager or relabeleraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Specification developeraccessdata.fda.gov
System, Colorectal Neoplasia, Dna Methylation And Hemoglobin DetectionPHP3Complaint file establishmentaccessdata.fda.gov
System, Test, C-Reactive ProteinDCN2Complaint file establishmentaccessdata.fda.gov
System, Test, Infectious MononucleosisKTN2Repackager or relabeleraccessdata.fda.gov
System, Test, Tumor Marker, For Detection Of Bladder CancerNAH3Manufacturer for exportaccessdata.fda.gov
System, Test, Tumor Marker, Monitoring, BladderMMW2Manufacturer, Specification developeraccessdata.fda.gov
Test, Erythrocyte Sedimentation RateJPH1Repackager or relabeleraccessdata.fda.gov
Test, Natriuretic PeptideNBC2Complaint file establishmentaccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 20, 2024K231974PATHFAST®hs-cTnI-IIMMISubstantially EquivalentPhc Corporationaccessdata.fda.gov
January 2, 2020K191147OC-Auto SENSOR io iFOB TestOOXSubstantially EquivalentEiken Chemical Co., Ltd.accessdata.fda.gov
August 20, 2015K143325OC-Light S FITKHESubstantially EquivalentEiken Chemical Co., Ltd.accessdata.fda.gov
September 9, 2013K132465BIOSIGN FLU A + B, STATUS FLU A & BPSZSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
May 16, 2011K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MMISubstantially EquivalentMitsubishi Chemical Medience COaccessdata.fda.gov
January 8, 2010K092330OC-SENSOR DIANA IFOB TESTOOXSubstantially EquivalentPolymedco Cancer Diagnostics, LLCaccessdata.fda.gov
August 17, 2009K081360PATHFAST CK-MB-II, PATHFAST MYO-IIJHXSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
May 6, 2009K072288PATHFAST D-DIMERGHHSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
March 9, 2009K083412PATHFAST HSCRPDCNSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
February 5, 2008K072189PATHFAST NTPROBNP AND D-DIMER TESTSNBCSubstantially EquivalentMitsubishi Kagaku Iatronaccessdata.fda.gov
November 22, 2004K040708STATUS FIRST STREP AGTYSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
October 21, 2004K041408POLYMEDCO OC AUTO MICRO 80 FOB TESTOOXSubstantially EquivalentPolymedco, Inc.accessdata.fda.gov
August 12, 2004K041297POLYMEDCO OC LIGHT FOBT TESTKHESubstantially EquivalentPolymedco, Inc.accessdata.fda.gov
May 23, 2002K020439STATUS HCG SERUM/URINEJHISubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
December 8, 1998K974845BTA STAT TEST PRESCRIPTION HOME USEMMWSubstantially EquivalentBard Diagnostic Sciences,Inc.accessdata.fda.gov
November 25, 1998K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTYSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
September 22, 1998K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYRSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
February 4, 1997K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTNSubstantially EquivalentPrinceton BioMeditech Corp.accessdata.fda.gov
February 23, 1993K924061CANCER ANTIGEN CONTROLJJYSubstantially EquivalentPolymedco, Inc.accessdata.fda.gov
April 29, 1992K921206HCG CONTROLJJXSubstantially EquivalentPolymedco, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 12, 2016P130001Epi proColonPHP6March 19, 2025accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
August 25, 202699810Class IIOngoingSEDIPLAST; Model/Catalog Numbers: S-100 and S-1000During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).accessdata.fda.gov
October 6, 202597860Class IIIOngoingOC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.accessdata.fda.gov
April 30, 201880724Class IITerminatedPATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused leakage through the pinhole. If the cartridge with leakage is used, higher measurement value as low as +12% and no higher than +20% bias may be obtained.accessdata.fda.gov
February 12, 201364537Class IITerminatedTest Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.accessdata.fda.gov
December 3, 200327874Not yet classifiedTerminatedPOLYMEDCO ULTRA-CRP High Sensitive Assay For the DIMENSION(R) systems, Catalog No. USC300. Contents: 4 x 50 Tests. For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFIFirm was notified by the foreign manufacturer that certain lots of Ultra-CRP are prone to prozone (a condition of antibody antigen excess) and do not meet the labeled specifications.accessdata.fda.gov

Compare with other makers

Updated October 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.