510(k) K822605

TOXOPLASMA GONDII ANTIBODY IGG by Immulok, Inc. — Product Code LJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1982
Date Received
August 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, If, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type