510(k) K863847

MIC - CONCEPT(TM) RX-2 by Microtech Medical Systems, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1986
Date Received
September 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type