Cleared Traditional

QUIKREAD CRP CALIBRATOR SET

K042625 · Orion Diagnostica, OY · Chemistry
Nov 2004
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K042625 is an FDA 510(k) clearance for the QUIKREAD CRP CALIBRATOR SET, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Orion Diagnostica, OY (Espoo, FI). The FDA issued a Cleared decision on November 18, 2004, 52 days after receiving the submission on September 27, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K042625 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2004
Decision Date November 18, 2004
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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