ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls— 510(k) K153375

Clearance details

Applicant

Abbott Laboratories

Product code

Code MRG

Device class

Class 2

Regulation

21 CFR 862.1825

Advisory panel

Clinical Chemistry

Date received

2015-11-23

Decision date

2016-08-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Abbott Park, IL, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153375.