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510(k) K221114

Device
Immunoglobulin G (IgG)
Applicant
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
510(k) number
K221114
Product code
CFN
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-02
Date received
2022-04-15
Regulation
866.5510
Classification name
Method, Nephelometric, Immunoglobulins (G, A, M)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tracy Jin
Address
# 181 W. Su Hong Rd., Suzhou Industrial Park Suzhou CN 215021 215021

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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