510(k) K952138

SAS FRANCISELLA TULARENSIS ANTIGEN by Sa Scientific, Inc. — Product Code GSL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1995
Date Received
May 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Slide And Tube, Francisella Tularensis
Device Class
Class II
Regulation Number
866.3280
Review Panel
MI
Submission Type