WELLCOGEN H. INFLUENZAL ZL21

Antiserum, Hai, Mumps Virus

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcogen H. Influenzal Zl21.

Pre-market Notification Details

• Device ID: K833077
• 510k Number: K833077
• Device Name: WELLCOGEN H. INFLUENZAL ZL21
• Classification: Antiserum, Hai, Mumps Virus
• Applicant: WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GRD
• CFR Regulation Number: 866.3380 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-09-09
• Decision Date: 1984-01-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05056080500966	K833077	000