FDA 510(k) Premarket Notification K151478: Wondfo CR3 Keyless Split Sample Cup

Submission Details & Decision

Normalized public record details for 510(k) notification K151478.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K151478

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

Wondfo CR3 Keyless Split Sample Cup

Product Code

DJG

Decision Date

2015-07-01

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Special

Third Party Flag

Date Received

2015-06-02

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