MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES

Tubes, Vials, Systems, Serum Separators, Blood Collection

GREINER BIO-ONE NORTH AMERICA, INC.

The following data is part of a premarket notification filed by Greiner Bio-one North America, Inc. with the FDA for Minicollect Capillary Blood Collection Tubes.

Pre-market Notification Details

• Device ID: K063357
• 510k Number: K063357
• Device Name: MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013
• Contact: Judi Smith
• Correspondent: Judi Smith; GREINER BIO-ONE NORTH AMERICA, INC. P.O. BOX 103 Baldwin, MD 21013
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-07
• Decision Date: 2007-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
39120017570425	K063357	000