Medical Device Manufacturer · CA , Charlottetown, Prin Ed Island

Genzyme Diagnostics P.E.I., Inc.

2 submissions · 2 cleared · Since 2008

Total

Cleared

Denied

Genzyme Diagnostics P.E.I., Inc. — FDA 510(k) Submissions

Genzyme Diagnostics P.E.I., Inc. has submitted 2 FDA 510(k) premarket notifications since 2008, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Colorimetry, Acetaminophen, Diazo Colorimetry, Bilirubin . Use the specialty filter in the sidebar to narrow results.

2 devices

1–2 of 2

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

K081938 · LDP Colorimetry, Acetaminophen · Toxicology

May 2009 297d

TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30

K082210 · CIG Diazo Colorimetry, Bilirubin · Chemistry

Dec 2008 132d

Data Source

FDA 510(k) public files . 174,402 total devices indexed.

Genzyme Diagnostics P.E.I., Inc.

Genzyme Diagnostics P.E.I., Inc. — FDA 510(k) Submissions

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