Cleared Traditional

WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006

K024305 · Wiener Laboratories Saic · Chemistry
Mar 2003
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K024305 is an FDA 510(k) clearance for the WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on March 18, 2003, 84 days after receiving the submission on December 24, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K024305 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2002
Decision Date March 18, 2003
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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