Polymedco, Inc.
Polymedco, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2011, with 2 FDA device recalls on record.
Top product codes for Polymedco, Inc.
FDA recalls by Polymedco, Inc.
- Z-1060-2013 — Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
- Z-1059-2013 — Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Polymedco, Inc.
- K112408 — POLY-CHEM 90 ISE MODULE
- K110818 — POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
- K111143 — POLY-CHEM 90 TOTAL BILIRUBIN
- K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K090703 — POLY-CHEM 90 GLUCOSE
- K061944 — POLY-CHEM CREATININE
- K053553 — NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
- K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST
- K041297 — POLYMEDCO OC LIGHT FOBT TEST
- K033706 — POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
- K023654 — GLYCA-DIRECT FRUCTOSAMINE
- K020852 — POLY-CHEM GLUCOSE
- K020532 — POLYMEDCO HBA1C TEST
- K012163 — POLYTITER SYSTEM
- K962049 — C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
- K955086 — TEST, RHEUMATOID FACTOR
- K924061 — CANCER ANTIGEN CONTROL
- K921206 — HCG CONTROL
- K915325 — TSH CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.