FDA 510(k) Premarket Notification K140089: CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)

Submission Details & Decision

Normalized public record details for 510(k) notification K140089.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K140089

Applicant / Sponsor

Guangzhou Wondfo Biotech Co., Ltd.

Device Name

CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)

Product Code

DJG

Decision Date

2014-04-08

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Toxicology (TX)

Clearance Type

Traditional

Third Party Flag

Date Received

2014-01-14

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