510(k) BK040066

Device

Blood Specimen Collection Devices - Vacuum

Applicant

Greiner Vacuette North America, Inc.

510(k) number

BK040066

Product code

JKA  

Decision

Substantially Equivalent (SE)

Decision date

2004-09-10

Date received

2004-08-18

Regulation

862.1675

Classification name

Tubes, Vials, Systems, Serum Separators, Blood Collection

Medical specialty

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Review panel

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Clearance type

510(k) Traditio

Third party reviewed

No