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510(k) K011079

Device
K-ASSAY HS-CRP CONTROLS
Applicant
Kamiya Biomedical Co.
510(k) number
K011079
Product code
DCK
Decision
Substantially Equivalent (SESE)
Decision date
2001-05-16
Date received
2001-04-09
Regulation
866.5270
Classification name
C-Reactive Protein, Antigen, Antiserum, And Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
COLIN GETTY
Address
910 Industry Dr. Seattle WA US 98188 98188

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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