Polymedco, Inc
FDA Regulatory Profile
Polymedco, Inc appears in FDA public data with 2 recalls, 19 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1060-2013, Class II) was initiated on February 12, 2013. Its most recent 510(k) clearance was granted on November 4, 2011.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1060-2013 | Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualita | February 12, 2013 |
| Z-1059-2013 | Class II | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitat | February 12, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K112408 | POLY-CHEM 90 ISE MODULE | November 4, 2011 |
| K110818 | POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS | September 8, 2011 |
| K111143 | POLY-CHEM 90 TOTAL BILIRUBIN | September 1, 2011 |
| K100550 | POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, | September 28, 2010 |
| K090703 | POLY-CHEM 90 GLUCOSE | October 20, 2009 |
| K061944 | POLY-CHEM CREATININE | November 3, 2006 |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | March 9, 2006 |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | October 21, 2004 |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | August 12, 2004 |
| K033706 | POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS | February 4, 2004 |
| K023654 | GLYCA-DIRECT FRUCTOSAMINE | May 2, 2003 |
| K020852 | POLY-CHEM GLUCOSE | July 3, 2002 |
| K020532 | POLYMEDCO HBA1C TEST | April 24, 2002 |
| K012163 | POLYTITER SYSTEM | August 20, 2001 |
| K962049 | C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT | December 18, 1996 |
| K955086 | TEST, RHEUMATOID FACTOR | December 20, 1995 |
| K924061 | CANCER ANTIGEN CONTROL | February 23, 1993 |
| K921206 | HCG CONTROL | April 29, 1992 |
| K915325 | TSH CONTROL | March 2, 1992 |