510(k) K905493

MERISTAR-MP by Meridian Diagnostics, Inc. — Product Code GSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
December 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Mycoplasma Spp.
Device Class
Class I
Regulation Number
866.3375
Review Panel
MI
Submission Type