WELLCOGEN GROUP B

Antisera, All Groups, Streptococcus Spp.

BURROUGHS WELLCOME CO.

The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Wellcogen Group B.

Pre-market Notification Details

• Device ID: K820069
• 510k Number: K820069
• Device Name: WELLCOGEN GROUP B
• Classification: Antisera, All Groups, Streptococcus Spp.
• Applicant: BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GTZ
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-01-12
• Decision Date: 1982-02-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05056080501574	K820069	000