Cleared Traditional

ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

K111335 · Tosoh Bioscience, Inc. · Chemistry
Dec 2011
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K111335 is an FDA 510(k) clearance for the ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321, a Radioimmunoassay, Acth (Class II — Special Controls, product code CKG), submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on December 1, 2011, 203 days after receiving the submission on May 12, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1025.

Submission Details

510(k) Number K111335 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2011
Decision Date December 01, 2011
Days to Decision 203 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKG — Radioimmunoassay, Acth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1025

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