
Sebia
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HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134 is an FDA 510(k)-cleared medical device (K022053) manufactured by Sebia. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 11, 2002. Regulation: 8.