Cleared Traditional

ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS

K973583 · Schiapparelli Biosystems, Inc. · Toxicology
Nov 1997
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K973583 is an FDA 510(k) clearance for the ACE THEOPHYLLINE REAGENT, THEO CALIBRATORS, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Schiapparelli Biosystems, Inc. (Fairfield, US). The FDA issued a Cleared decision on November 12, 1997, 51 days after receiving the submission on September 22, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K973583 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1997
Decision Date November 12, 1997
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLS — Enzyme Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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