TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11

Counter, Differential Cell

MILES, INC.

The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Technicon H*1 Systems, Labfacts Software For U.i.w. Versions 4.11 & 5.11.

Pre-market Notification Details

Device IDK933478
510k NumberK933478
Device Name:TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11
ClassificationCounter, Differential Cell
Applicant MILES, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
ContactGabriel J Muraca, Jr.
CorrespondentGabriel J Muraca, Jr.
MILES, INC. 511 BENEDICT AVE. Tarrytown,  NY  10591 -5097
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-16
Decision Date1993-11-22

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