GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR

Tubes, Vials, Systems, Serum Separators, Blood Collection

GREINER AMERICA, INC.

The following data is part of a premarket notification filed by Greiner America, Inc. with the FDA for Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator.

Pre-market Notification Details

• Device ID: K960858
• 510k Number: K960858
• Device Name: GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: GREINER AMERICA, INC. 7 HENRY CT. Wilmington, DE 19808
• Contact: Ed Maier
• Correspondent: Ed Maier; GREINER AMERICA, INC. 7 HENRY CT. Wilmington, DE 19808
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-03-01
• Decision Date: 1996-08-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10889942214884	K960858	000
39120126130992	K960858	000
39120126130985	K960858	000
39120126131012	K960858	000