FDA 510(k) Premarket Notification K083412: PATHFAST HSCRP

Submission Details & Decision

Normalized public record details for 510(k) notification K083412.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K083412

Applicant / Sponsor

Mitsubishi Kagaku Iatron

Device Name

PATHFAST HSCRP

Product Code

DCN

Decision Date

2009-03-09

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Immunology (IM)

Clearance Type

Traditional

Third Party Flag

Date Received

2008-11-18

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