Polymedco, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1060-2013Class IITest Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitaFebruary 12, 2013
Z-1059-2013Class IITest Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitatFebruary 12, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K112408POLY-CHEM 90 ISE MODULENovember 4, 2011
K110818POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTSSeptember 8, 2011
K111143POLY-CHEM 90 TOTAL BILIRUBINSeptember 1, 2011
K100550POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, September 28, 2010
K090703POLY-CHEM 90 GLUCOSEOctober 20, 2009
K061944POLY-CHEM CREATININENovember 3, 2006
K053553NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROLMarch 9, 2006
K041408POLYMEDCO OC AUTO MICRO 80 FOB TESTOctober 21, 2004
K041297POLYMEDCO OC LIGHT FOBT TESTAugust 12, 2004
K033706POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMSFebruary 4, 2004
K023654GLYCA-DIRECT FRUCTOSAMINEMay 2, 2003
K020852POLY-CHEM GLUCOSEJuly 3, 2002
K020532POLYMEDCO HBA1C TESTApril 24, 2002
K012163POLYTITER SYSTEMAugust 20, 2001
K962049C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KITDecember 18, 1996
K955086TEST, RHEUMATOID FACTORDecember 20, 1995
K924061CANCER ANTIGEN CONTROLFebruary 23, 1993
K921206HCG CONTROLApril 29, 1992
K915325TSH CONTROLMarch 2, 1992