ISOLATOR SYSTEM

Tubes, Vials, Systems, Serum Separators, Blood Collection

E.I. DUPONT DE NEMOURS & CO., INC.

The following data is part of a premarket notification filed by E.i. Dupont De Nemours & Co., Inc. with the FDA for Isolator System.

Pre-market Notification Details

• Device ID: K810664
• 510k Number: K810664
• Device Name: ISOLATOR SYSTEM
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: E.I. DUPONT DE NEMOURS & CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-03-11
• Decision Date: 1981-03-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10811877010965	K810664	000