Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC
Cortlandt Manor, NY, US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. appears in FDA device records in Cortlandt Manor, NY. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Polymedco, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC between 1992 and 2011. The busiest year on record is 2004, with 3. The most recent is 2011, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 1 |
| 1995 | 1 |
| 1996 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 3 |
| 2006 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K112408 | POLY-CHEM 90 ISE MODULE | CEM | Substantially Equivalent | |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | CIX | Substantially Equivalent | |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC | LBS | Substantially Equivalent | |
| K090703 | POLY-CHEM 90 GLUCOSE | CFR | Substantially Equivalent | |
| K061944 | POLY-CHEM CREATININE | JFY | Substantially Equivalent | |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | DCF | Substantially Equivalent | |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | OOX | Substantially Equivalent | |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | KHE | Substantially Equivalent | |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | LPS | Substantially Equivalent | |
| K023654 | GLYCA-DIRECT FRUCTOSAMINE | LCP | Substantially Equivalent | |
| K020852 | POLY-CHEM GLUCOSE | CFR | Substantially Equivalent | |
| K020532 | POLYMEDCO HBA1C TEST | LCP | Substantially Equivalent | |
| K012163 | POLYTITER SYSTEM | DHN | Substantially Equivalent | |
| K962049 | C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT | DCK | Substantially Equivalent | |
| K955086 | TEST, RHEUMATOID FACTOR | DHR | Substantially Equivalent | |
| K924061 | CANCER ANTIGEN CONTROL | JJY | Substantially Equivalent | |
| K921206 | HCG CONTROL | JJX | Substantially Equivalent | |
| K915325 | TSH CONTROL | JJX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2435505 | 1000119795 | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC. | 510 FURNACE DOCK RD., CORTLANDT MANOR, NY 10567 US | 2026 | and 13 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DCFAlbumin, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- GTYAntigens, All Groups, Streptococcus Spp.
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- LCPAssay, Glycosylated Hemoglobin
- OOXAutomated Occult Blood Analyzer
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JITCalibrator, Secondary
- PSZDevices Detecting Influenza A, B, And C Virus Antigens
- CIGDiazo Colorimetry, Bilirubin
- CEMElectrode, Ion Specific, Potassium
- JFYEnzymatic Method, Creatinine
- GHHFibrin Split Products
- JHXFluorometric Method, Cpk Or Isoenzymes
- LYRHelicobacter Pylori
- CFRHexokinase, Glucose
- MMIImmunoassay Method, Troponin Subunit
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JRCMicro Pipette
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- JHERadioassay, 17-Hydroxycorticosteroids
- KHEReagent, Occult Blood
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- DCNSystem, Test, C-Reactive Protein
- KTNSystem, Test, Infectious Mononucleosis
- DHRSystem, Test, Rheumatoid Factor
- NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer
- MMWSystem, Test, Tumor Marker, Monitoring, Bladder
- JPHTest, Erythrocyte Sedimentation Rate
- NBCTest, Natriuretic Peptide
- LPSUrinary Homocystine (Nonquantitative) Test System
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0538-2026 | OC-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. | Class III | Open, Classified | |
| Z-3186-2018 | PATHFAST NTproBNP Catalog Number: PF1061-KUS 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 B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. | 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. | Class II | Terminated | |
| Z-3185-2018 | PATHFAST 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 B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. | 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. | Class II | Terminated | |
| Z-1060-2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. 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. | Class II | Terminated | |
| Z-1059-2013 | Test 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. | Class II | Terminated | |
| Z-0296-04 | POLYMEDCO ULTRA-CRP LATEX ENHANCED ASSAY, Catalog No. CPU400. Contents: 1 x 50 ML R1, 2 x 6 ML R2. R1 is the HIGH SENSITIVE CRP Buffer IVD (50 ml). R2 is the HIGH SENSITIVE CRP Latex IVD (6 ml). For In Vitro Diagnostic (IVD) use only. COMMON/USUAL NAME: High-Sensitive C-Reactive Protein --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum | Firm 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. | Terminated | ||
| Z-0295-04 | POLYMEDCO 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 --- CLASSIFICATION NAME: C-reactive Protein, Antigen, Antiserum. | Firm 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain