510(k) K860034

PARA-PAK MACRO-CON by Meridian Diagnostics, Inc. — Product Code LKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1986
Date Received
January 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Parasite Concentration
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type