LYFO(TM) DIFFERIENTAL DISK-PYR

Discs, Strips And Reagents, Microorganism Differentiation

MICRO BIO LOGICS, INC.

The following data is part of a premarket notification filed by Micro Bio Logics, Inc. with the FDA for Lyfo(tm) Differiental Disk-pyr.

Pre-market Notification Details

Device IDK954812
510k NumberK954812
Device Name:LYFO(TM) DIFFERIENTAL DISK-PYR
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant MICRO BIO LOGICS, INC. 217 OSSEO AVE. NORTH St. Cloud,  MN  56303 -4452
ContactGeri Hotz
CorrespondentGeri Hotz
MICRO BIO LOGICS, INC. 217 OSSEO AVE. NORTH St. Cloud,  MN  56303 -4452
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-19
Decision Date1995-12-20

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