Cleared Traditional

BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT

K013062 · Biocheck, Inc. · Chemistry
Jan 2002
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K013062 is an FDA 510(k) clearance for the BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on January 8, 2002, 118 days after receiving the submission on September 12, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K013062 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2001
Decision Date January 08, 2002
Days to Decision 118 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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