CLINIFACTS 200 DATA MANAGEMENT SYSTEM

Calculator/data Processing Module, For Clinical Use

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Clinifacts 200 Data Management System.

Pre-market Notification Details

Device IDK861778
510k NumberK861778
Device Name:CLINIFACTS 200 DATA MANAGEMENT SYSTEM
ClassificationCalculator/data Processing Module, For Clinical Use
Applicant MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
ContactJohn H Engelmann
CorrespondentJohn H Engelmann
MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
Product CodeJQP  
CFR Regulation Number862.2100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-08
Decision Date1986-07-02

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