Cleared Abbreviated

RDI HS CRP CALIBRATOR SET

K021607 · Reference Diagnostics, Inc. · Immunology
Jun 2002
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K021607 is an FDA 510(k) clearance for the RDI HS CRP CALIBRATOR SET, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on June 27, 2002, 42 days after receiving the submission on May 16, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K021607 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2002
Decision Date June 27, 2002
Days to Decision 42 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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