Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Polymedco, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K112408 POLY-CHEM 90 ISE MODULECEM2011-11-04 View
510(k) K110818 POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTSCIX2011-09-08 View
510(k) K111143 POLY-CHEM 90 TOTAL BILIRUBINCIG2011-09-01 View
510(k) K100550 POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYCLBS2010-09-28 View
510(k) K090703 POLY-CHEM 90 GLUCOSECFR2009-10-20 View
510(k) K061944 POLY-CHEM CREATININEJFY2006-11-03 View
510(k) K053553 NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROLDCF2006-03-09 View
510(k) K041408 POLYMEDCO OC AUTO MICRO 80 FOB TESTOOX2004-10-21 View
510(k) K041297 POLYMEDCO OC LIGHT FOBT TESTKHE2004-08-12 View
510(k) K033706 POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMSLPS2004-02-04 View
510(k) K023654 GLYCA-DIRECT FRUCTOSAMINELCP2003-05-02 View
510(k) K020852 POLY-CHEM GLUCOSECFR2002-07-03 View
510(k) K020532 POLYMEDCO HBA1C TESTLCP2002-04-24 View
510(k) K012163 POLYTITER SYSTEMDHN2001-08-20 View
510(k) K962049 C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KITDCK1996-12-18 View
510(k) K955086 TEST, RHEUMATOID FACTORDHR1995-12-20 View
510(k) K924061 CANCER ANTIGEN CONTROLJJY1993-02-23 View
510(k) K921206 HCG CONTROLJJX1992-04-29 View
510(k) K915325 TSH CONTROLJJX1992-03-02 View
↑