Cleared Traditional

ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls

K153375 · Abbott Laboratories · Chemistry

Aug 2016

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K153375 is an FDA 510(k) clearance for the ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 12, 2016, 263 days after receiving the submission on November 23, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number	K153375 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2015
Decision Date	August 12, 2016
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF