510(k) K924395

NEOTHROMITIN(R) by Behring Diagnostics, Inc. — Product Code GPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1992
Date Received
August 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, Typhus Fever Group
Device Class
Class I
Regulation Number
866.3500
Review Panel
MI
Submission Type