Cleared Traditional

BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116

K041619 · Biocheck, Inc. · Chemistry
Dec 2004
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K041619 is an FDA 510(k) clearance for the BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116, 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 December 17, 2004, 185 days after receiving the submission on June 15, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K041619 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2004
Decision Date December 17, 2004
Days to Decision 185 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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