FDA.reportPublic FDA data

510(k) K031682

Device
LIPOPROTEIN CALIBRATOR
Applicant
Bayer Healthcare, LLC
510(k) number
K031682
Product code
JIX
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-25
Date received
2003-05-30
Regulation
862.1150
Classification name
Calibrator, Multi-Analyte Mixture
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
KENNETH T EDDS
Address
511 Benedict Ave. Tarrytown NY US 10591 10591

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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