Cleared Traditional

SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936

K010652 · Sigma Diagnostics, Inc. · Chemistry
Mar 2001
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K010652 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 30, 2001, 25 days after receiving the submission on March 5, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K010652 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2001
Decision Date March 30, 2001
Days to Decision 25 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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