Cleared Traditional

IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP

K003372 · Diagnostic Products Corp. · Immunology
Dec 2000
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K003372 is an FDA 510(k) clearance for the IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 26, 2000, 57 days after receiving the submission on October 30, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K003372 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2000
Decision Date December 26, 2000
Days to Decision 57 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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