Cleared Traditional

AIA-PACK CTNI 2ND-GEN ASSAY

K012820 · Tosoh Medics, Inc. · Chemistry
Dec 2001
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K012820 is an FDA 510(k) clearance for the AIA-PACK CTNI 2ND-GEN ASSAY, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on December 14, 2001, 113 days after receiving the submission on August 23, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K012820 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2001
Decision Date December 14, 2001
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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