Cleared Abbreviated

RAICHEM MULTI-ANALYTE CALIBRATOR

K012250 · Hemagen Diagnostics, Inc. · Chemistry
Sep 2001
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K012250 is an FDA 510(k) clearance for the RAICHEM MULTI-ANALYTE CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on September 24, 2001, 69 days after receiving the submission on July 17, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K012250 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2001
Decision Date September 24, 2001
Days to Decision 69 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIX — Calibrator, Multi-analyte Mixture
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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