FDA.report

510(k) K203248

Device
Albumin BCG2
Applicant
Abbott Ireland Diagnostics Division
510(k) number
K203248
Product code
CIX
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-23
Date received
2020-11-04
Regulation
862.1035
Classification name
Bromcresol Green Dye-Binding, Albumin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Suzanne Cheang
Address
Lisnamuck Longford IE

FDA Registration Numbers

Source Documents

510(k) summary PDF

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