FDA 510(k) Premarket Notification K133067: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT

Submission Details & Decision

Normalized public record details for 510(k) notification K133067.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K133067

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT

Product Code

CDT

Decision Date

2013-11-22

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

2013-09-27

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