Cleared Traditional

THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS

K942192 · Sigma Diagnostics, Inc. · Chemistry
Jul 1994
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K942192 is an FDA 510(k) clearance for the THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS, a Fluorescent Immunoassay, Theophylline (Class II — Special Controls, product code LER), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 13, 1994, 70 days after receiving the submission on May 4, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K942192 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1994
Decision Date July 13, 1994
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code LER — Fluorescent Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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