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. Chemistry ✕

1 devices
1-1 of 1
Cleared Dec 16, 2008
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
K082210 · CIG
Chemistry · 132d
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