510(k) K950169

RIBOSOMAL P EIA TEST SYSTEM by Hogan & Hartson — Product Code MQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1996
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Ribosomal P Antibodies
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type