CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM

Automated Urinalysis System

MILES INC., DENTAL PRODUCTS

The following data is part of a premarket notification filed by Miles Inc., Dental Products with the FDA for Clinitek Atlas Automated Urine Chemistry System.

Pre-market Notification Details

Device IDK932674
510k NumberK932674
Device Name:CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM
ClassificationAutomated Urinalysis System
Applicant MILES INC., DENTAL PRODUCTS 4315 S. LAFAYETTE BLVD. South Bend,  IN  46614
ContactRosanne M Soval
CorrespondentRosanne M Soval
MILES INC., DENTAL PRODUCTS 4315 S. LAFAYETTE BLVD. South Bend,  IN  46614
Product CodeKQO  
CFR Regulation Number862.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-02
Decision Date1993-08-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414374109 K932674 000
00630414373201 K932674 000
00630414373027 K932674 000
00630414373003 K932674 000
00630414372464 K932674 000
00630414372181 K932674 000

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