Cleared Traditional

STA - FREE PS CALIBRATOR

K092113 · Diagnostica Stago, Inc. · Hematology
Nov 2009
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K092113 is an FDA 510(k) clearance for the STA - FREE PS CALIBRATOR, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on November 13, 2009, 122 days after receiving the submission on July 14, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K092113 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2009
Decision Date November 13, 2009
Days to Decision 122 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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