Cleared Traditional

CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)

K040579 · Cholestech Corp. · Chemistry
Jun 2004
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K040579 is an FDA 510(k) clearance for the CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP), a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Cholestech Corp. (Hayward, US). The FDA issued a Cleared decision on June 18, 2004, 106 days after receiving the submission on March 4, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K040579 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2004
Decision Date June 18, 2004
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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