Cleared Traditional

NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET

K900009 · Kallestad Diag, A Div. of Erbamont, Inc. · Toxicology
Mar 1990
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K900009 is an FDA 510(k) clearance for the NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 29, 1990, 86 days after receiving the submission on January 2, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K900009 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1990
Decision Date March 29, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

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