WELLCOGEN S. PNEUMONIAE

Antisera, All Types, Streptococcus Pneumoniae

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcogen S. Pneumoniae.

Pre-market Notification Details

• Device ID: K841376
• 510k Number: K841376
• Device Name: WELLCOGEN S. PNEUMONIAE
• Classification: Antisera, All Types, Streptococcus Pneumoniae
• Applicant: WELLCOME DIAGNOSTICS 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: GWC
• CFR Regulation Number: 866.3740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-04-03
• Decision Date: 1984-05-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05056080501581	K841376	000