Cleared Traditional

BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114

K040030 · Biocheck, Inc. · Immunology
Jun 2004
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K040030 is an FDA 510(k) clearance for the BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on June 16, 2004, 161 days after receiving the submission on January 7, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K040030 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2004
Decision Date June 16, 2004
Days to Decision 161 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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