Cleared Traditional

Abbott ARCHITECT Free T3

K170160 · Abbott Laboratories · Chemistry
Feb 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K170160 is an FDA 510(k) clearance for the Abbott ARCHITECT Free T3, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Abbott Laboratories (Abbot Park, US). The FDA issued a Cleared decision on February 15, 2017, 28 days after receiving the submission on January 18, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K170160 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 2017
Decision Date February 15, 2017
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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