FDA 510(k) Premarket Notification K013373: OMNI C ANALYZER

Submission Details & Decision

Normalized public record details for 510(k) notification K013373.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K013373

Applicant / Sponsor

Roche Diagnostics Corp.

Device Name

OMNI C ANALYZER

Product Code

CEM

Decision Date

2001-11-02

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Special

Third Party Flag

Date Received

2001-10-11

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