COULTER CHECK SAMPLE UNASSAYED HEMATOLOG

Mixture, Hematology Quality Control

COULTER ELECTRONICS, INC.

The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Coulter Check Sample Unassayed Hematolog.

Pre-market Notification Details

Device IDK843805
510k NumberK843805
Device Name:COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
ClassificationMixture, Hematology Quality Control
Applicant COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
ContactRichardson-jones
CorrespondentRichardson-jones
COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJPK  
CFR Regulation Number864.8625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-27
Decision Date1984-12-17

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