510(k) K821411

HISTOSET IMMUNOPEROFIDASE TISSUE by Immulok, Inc. — Product Code GQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
May 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type