Cleared Traditional

ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01

K082953 · Biokit, S.A. · Toxicology
Dec 2008
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K082953 is an FDA 510(k) clearance for the ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01, a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on December 22, 2008, 80 days after receiving the submission on October 3, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K082953 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2008
Decision Date December 22, 2008
Days to Decision 80 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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