Cleared Traditional

ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)

K070810 · Biokit, S.A. · Toxicology
Jun 2007
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K070810 is an FDA 510(k) clearance for the ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F), a Fluorescence Polarization Immunoassay, Theophylline (Class II — Special Controls, product code LGS), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on June 8, 2007, 74 days after receiving the submission on March 26, 2007. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3880.

Submission Details

510(k) Number K070810 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2007
Decision Date June 08, 2007
Days to Decision 74 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LGS — Fluorescence Polarization Immunoassay, Theophylline
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3880

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