Genzyme Diagnostics P.E.I., Inc. is one of 691 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Genzyme Diagnostics P.E.I., Inc. - FDA 510(k) Cleared Devices
Recent clearances: ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30, TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
2
Total
2
Cleared
0
Denied
Genzyme Diagnostics P.E.I., Inc. has 2 FDA 510(k) cleared medical devices. Based in Charlottetown, Prin Ed Island, CA.
Historical record: 2 cleared submissions from 2008 to 2009. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Genzyme Diagnostics P.E.I., Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genzyme Diagnostics P.E.I., Inc.
2 devices