Polymedco, Inc. - FDA 510(k) Cleared Devices
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Polymedco, Inc. Chemistry ✕
12 devices
Cleared
Nov 04, 2011
POLY-CHEM 90 ISE MODULE
Chemistry
74d
Cleared
Sep 08, 2011
POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL...
Chemistry
168d
Cleared
Sep 01, 2011
POLY-CHEM 90 TOTAL BILIRUBIN
Chemistry
132d
Cleared
Sep 28, 2010
POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL,...
Chemistry
214d
Cleared
Oct 20, 2009
POLY-CHEM 90 GLUCOSE
Chemistry
217d
Cleared
Nov 03, 2006
POLY-CHEM CREATININE
Chemistry
116d
Cleared
Mar 09, 2006
NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
Chemistry
79d
Cleared
Feb 04, 2004
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
Chemistry
70d
Cleared
May 02, 2003
GLYCA-DIRECT FRUCTOSAMINE
Chemistry
184d
Cleared
Jul 03, 2002
POLY-CHEM GLUCOSE
Chemistry
110d
Cleared
Apr 29, 1992
HCG CONTROL
Chemistry
47d
Cleared
Mar 02, 1992
TSH CONTROL
Chemistry
101d