Cleared Traditional

THEOPHYLLINE ENZYME IMMUNOASSAY

K952596 · Diagnostic Reagents, Inc. · Toxicology
Aug 1995
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K952596 is an FDA 510(k) clearance for the THEOPHYLLINE ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Theophylline (Class II — Special Controls, product code KLS), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 11, 1995, 66 days after receiving the submission on June 6, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K952596 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1995
Decision Date August 11, 1995
Days to Decision 66 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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