Medical Device Manufacturer · US , Cortlandt Manor , NY

Polymedco, Inc.

19 submissions · 19 cleared · Since 1992
19
Total
19
Cleared
0
Denied

Polymedco, Inc. — FDA 510(k) Submissions

Polymedco, Inc. has submitted 19 FDA 510(k) premarket notifications since 1992, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Single (specified) Analyte Controls (assayed And Unassayed), Hexokinase, Glucose, Multi-analyte Controls, All Kinds (assayed), Urinary Homocystine (nonquantitative) Test System . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
POLY-CHEM 90 ISE MODULE
K112408 · CEM Electrode, Ion Specific,... · Chemistry
Nov 2011 74d
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
K110818 · CIX Bromcresol Green... · Chemistry
Sep 2011 168d
POLY-CHEM 90 TOTAL BILIRUBIN
K111143 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Sep 2011 132d
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
K100550 · LBS Ldl & Vldl Precipitation,... · Chemistry
Sep 2010 214d
POLY-CHEM 90 GLUCOSE
K090703 · CFR Hexokinase, Glucose · Chemistry
Oct 2009 217d
POLY-CHEM CREATININE
K061944 · JFY Enzymatic Method, Creatinine · Chemistry
Nov 2006 116d
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
K053553 · DCF Albumin, Antigen,... · Chemistry
Mar 2006 79d
POLYMEDCO OC AUTO MICRO 80 FOB TEST
K041408 · OOX Automated Occult Blood... · Hematology
Oct 2004 147d
POLYMEDCO OC LIGHT FOBT TEST
K041297 · KHE Reagent, Occult Blood · Hematology
Aug 2004 90d
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706 · LPS Urinary Homocystine... · Chemistry
Feb 2004 70d
GLYCA-DIRECT FRUCTOSAMINE
K023654 · LCP Assay, Glycosylated... · Chemistry
May 2003 184d
POLY-CHEM GLUCOSE
K020852 · CFR Hexokinase, Glucose · Chemistry
Jul 2002 110d
POLYMEDCO HBA1C TEST
K020532 · LCP Assay, Glycosylated... · Hematology
Apr 2002 64d
POLYTITER SYSTEM
K012163 · DHN Antinuclear Antibody,... · Immunology
Aug 2001 40d
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
K962049 · DCK C-reactive Protein,... · Immunology
Dec 1996 204d
TEST, RHEUMATOID FACTOR
K955086 · DHR System, Test, Rheumatoid... · Immunology
Dec 1995 43d
CANCER ANTIGEN CONTROL
K924061 · JJY Multi-analyte Controls,... · Immunology
Feb 1993 195d
HCG CONTROL
K921206 · JJX Single (specified)... · Chemistry
Apr 1992 47d
TSH CONTROL
K915325 · JJX Single (specified)... · Chemistry
Mar 1992 101d
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