COULTER LH 500 HEMATOLOGY ANALYZER

Counter, Differential Cell

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Coulter Lh 500 Hematology Analyzer.

Pre-market Notification Details

Device IDK032000
510k NumberK032000
Device Name:COULTER LH 500 HEMATOLOGY ANALYZER
ClassificationCounter, Differential Cell
Applicant BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami,  FL  33196 -2500
ContactStan Sugrue
CorrespondentStan Sugrue
BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 Miami,  FL  33196 -2500
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-10
Decision Date2003-08-13
Summary:summary

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