FDA.report

510(k) K240468

Device
Alkaline Phosphatase
Applicant
Abbott Laboratories Diagnostics Division
510(k) number
K240468
Product code
CJE
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-16
Date received
2024-02-20
Regulation
862.1050
Classification name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Bryant Tate
Address
1915 Hurd Dr. Dept. Ra11, Bldg. Lc 8 - 4th Floor Ms 8-9 Irving TX US 75038 75038

FDA Registration Numbers

Source Documents

510(k) summary PDF

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