LYFO(TM) DIFFERENTIAL DISK-SPS

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) Differential Disk-sps.

Pre-market Notification Details

Device IDK945880
510k NumberK945880
Device Name:LYFO(TM) DIFFERENTIAL DISK-SPS
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 Received1994-12-01
Decision Date1995-04-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.