Cleared Traditional

BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119

K003851 · Biocheck, Inc. · Chemistry
Jul 2001
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K003851 is an FDA 510(k) clearance for the BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on July 20, 2001, 220 days after receiving the submission on December 12, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K003851 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2000
Decision Date July 20, 2001
Days to Decision 220 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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