510(k) K821249

ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS by Electro-Nucleonics Laboratories, Inc. — Product Code GRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
April 30, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Rubeola
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type