Medical Device Manufacturer · CA , Charlottetown, Prin Ed Island

Genzyme Diagnostics P.E.I., Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2008

Recent clearances: ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30, TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genzyme Diagnostics P.E.I., Inc. Toxicology ✕

1 devices

1-1 of 1

Cleared May 01, 2009

ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30

Toxicology · 297d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 01, 2026