Cleared Abbreviated

RDI EXTENDED RANGE CRP CALIBRATOR SET

K030772 · Reference Diagnostics, Inc. · Immunology
Apr 2003
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K030772 is an FDA 510(k) clearance for the RDI EXTENDED RANGE 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 April 11, 2003, 31 days after receiving the submission on March 11, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K030772 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2003
Decision Date April 11, 2003
Days to Decision 31 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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