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510(k) K833077

WELLCOGEN H. INFLUENZAL ZL21 by Wellcome Diagnostics — Product Code GRD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
September 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Hai, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
Review Panel
MI
Submission Type

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