Company ยท US
Polymedco, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2011. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 |
| KHE | Reagent, Occult Blood | 3 |
| CFR | Hexokinase, Glucose | 2 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 2 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| DCF | Albumin, Antigen, Antiserum, Control | 1 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| LPS | Urinary Homocystine (Nonquantitative) Test System | 1 |
| OOX | Automated Occult Blood Analyzer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 4, 2011 | K112408 | POLY-CHEM 90 ISE MODULE Polymedco, Inc. | CEM |
| Sep 8, 2011 | K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS Polymedco, Inc. | CIX |
| Sep 1, 2011 | K111143 | POLY-CHEM 90 TOTAL BILIRUBIN Polymedco, Inc. | CIG |
| Sep 28, 2010 | K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC Polymedco, Inc. | LBS |
| Oct 20, 2009 | K090703 | POLY-CHEM 90 GLUCOSE Polymedco, Inc. | CFR |
| Nov 3, 2006 | K061944 | POLY-CHEM CREATININE Polymedco, Inc. | JFY |
| Mar 9, 2006 | K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL Polymedco, Inc. | DCF |
| Oct 21, 2004 | K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST Polymedco, Inc. | OOX |
| Aug 12, 2004 | K041297 | POLYMEDCO OC LIGHT FOBT TEST Polymedco, Inc. | KHE |
| Feb 4, 2004 | K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS Polymedco, Inc. | LPS |
| May 2, 2003 | K023654 | GLYCA-DIRECT FRUCTOSAMINE Polymedco, Inc. | LCP |
| Jul 3, 2002 | K020852 | POLY-CHEM GLUCOSE Polymedco, Inc. | CFR |
| Apr 24, 2002 | K020532 | POLYMEDCO HBA1C TEST Polymedco, Inc. | LCP |
| Aug 20, 2001 | K012163 | POLYTITER SYSTEM Polymedco, Inc. | DHN |
| Dec 18, 1996 | K962049 | C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT Polymedco, Inc. | DCK |
| Dec 20, 1995 | K955086 | TEST, RHEUMATOID FACTOR Polymedco, Inc. | DHR |
| Feb 23, 1993 | K924061 | CANCER ANTIGEN CONTROL Polymedco, Inc. | JJY |
| Apr 29, 1992 | K921206 | HCG CONTROL Polymedco, Inc. | JJX |
| Mar 2, 1992 | K915325 | TSH CONTROL Polymedco, Inc. | JJX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2013 | Polymedco, Inc Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR.
For the rapid, qualitative detection of human hemoglobin in feces. Terminated |
KHE | None listed |
| Apr 4, 2013 | Polymedco, Inc Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50.
For the rapid, qualitative detection of human hemoglobin in feces. Terminated |
KHE | K041297 |
| Jan 6, 2004 | Polymedco, Inc 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 Terminated |
DCK | K001009 |
| Jan 6, 2004 | Polymedco, Inc 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-Reactiv Terminated |
DCK | K001009 |