Cleared Traditional

ST AIA-PACK PROG III Calibrator Set

K153417 · Tosoh Bioscience, Inc. · Chemistry
Dec 2015
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K153417 is an FDA 510(k) clearance for the ST AIA-PACK PROG III 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 December 18, 2015, 23 days after receiving the submission on November 25, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K153417 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2015
Decision Date December 18, 2015
Days to Decision 23 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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