Cleared Abbreviated

FERRITIN CALIBRATOR SET, CATALOG NO. 8203

K053291 · Reference Diagnostics, Inc. · Chemistry
Mar 2006
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K053291 is an FDA 510(k) clearance for the FERRITIN CALIBRATOR SET, CATALOG NO. 8203, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on March 13, 2006, 108 days after receiving the submission on November 25, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K053291 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2005
Decision Date March 13, 2006
Days to Decision 108 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
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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