Cleared Traditional

RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

K021194 · Hemagen Diagnostics, Inc. · Chemistry
Jul 2002
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K021194 is an FDA 510(k) clearance for the RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on July 29, 2002, 105 days after receiving the submission on April 15, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K021194 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2002
Decision Date July 29, 2002
Days to Decision 105 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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