Polymedco, Inc.
Medical device manufacturer in Cortlandt Manor, NY.
19510(k) clearances
0PMA approvals
2recalls
Device types
- JJX Single (Specified) Analyte Controls… 2
- LCP Assay, Glycosylated Hemoglobin 2
- CFR Hexokinase, Glucose 2
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- DHR System, Test, Rheumatoid Factor 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
- DHN Antinuclear Antibody, Indirect… 1
- LPS Urinary Homocystine (Nonquantitative) Test… 1
- KHE Reagent, Occult Blood 1
- OOX Automated Occult Blood Analyzer 1
- DCF Albumin, Antigen, Antiserum, Control 1
- JFY Enzymatic Method, Creatinine 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- CIG Diazo Colorimetry, Bilirubin 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CEM Electrode, Ion Specific, Potassium 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K112408 | Poly-Chem 90 Ise ModuleCEM · Traditional | 11/04/2011SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | 09/08/2011SE |
| K111143 | Poly-Chem 90 Total BilirubinCIG · Traditional | 09/01/2011SE |
| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | 09/28/2010SE |
| K090703 | Poly-Chem 90 GlucoseCFR · Traditional | 10/20/2009SE |
| K061944 | Poly-Chem CreatinineJFY · Traditional | 11/03/2006SE |
| K053553 | Nycocard U-Albumin and U-Albumin ControlDCF · Traditional | 03/09/2006SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | 10/21/2004SE |
| K041297 | Polymedco Oc Light Fobt TestKHE · Traditional | 08/12/2004SE |
| K033706 | Polymedco Homocysteine Test for the Poly-Chem and Hitachi Chemistry SystemsLPS · Traditional | 02/04/2004SE |
| K023654 | Glyca-Direct FructosamineLCP · Traditional | 05/02/2003SE |
| K020852 | Poly-Chem GlucoseCFR · Traditional | 07/03/2002SE |
| K020532 | Polymedco HBA1C TestLCP · Traditional | 04/24/2002SE |
| K012163 | Polytiter SystemDHN · Traditional | 08/20/2001SE |
| K962049 | C-Reactive Protein (CRP) Agglutination Latex KitDCK · Traditional | 12/18/1996SE |
| K955086 | Test, Rheumatoid FactorDHR · Traditional | 12/20/1995SE |
| K924061 | Cancer Antigen ControlJJY · Traditional | 02/23/1993SE |
| K921206 | HCG ControlJJX · Traditional | 04/29/1992SE |
| K915325 | TSH ControlJJX · Traditional | 03/02/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1060-2013 Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the…The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being… | 02/12/2013Terminated |
| Z-1059-2013 Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid…The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being… | 02/12/2013Terminated |