510(k) K951889

LYFO(TM) DIFFERENTIAL DISK by Microbiologics, Inc. — Product Code JTO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
April 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Strips And Reagents, Microorganism Differentiation
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type