Cleared Traditional

AXSYM PHENOBARBITAL

K940596 · Abbott Laboratories · Toxicology
Jun 1994
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K940596 is an FDA 510(k) clearance for the AXSYM PHENOBARBITAL, a Fluorescence Polarization Immunoassay, Phenobarbital (Class II — Special Controls, product code LGQ), submitted by Abbott Laboratories (Spartanburg, US). The FDA issued a Cleared decision on June 21, 1994, 131 days after receiving the submission on February 10, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K940596 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1994
Decision Date June 21, 1994
Days to Decision 131 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LGQ — Fluorescence Polarization Immunoassay, Phenobarbital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3660

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