Cleared Traditional

ST AIA-PACK hsE2 Calibrator Set

K160113 · Tosoh Bioscience, Inc. · Chemistry
Feb 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K160113 is an FDA 510(k) clearance for the ST AIA-PACK hsE2 Calibrator Set, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on February 17, 2016, 29 days after receiving the submission on January 19, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K160113 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2016
Decision Date February 17, 2016
Days to Decision 29 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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