Cleared Traditional

FPR PHENOBARBITAL KIT

K894525 · Colony Laboratories, Inc. · Toxicology
Aug 1989
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K894525 is an FDA 510(k) clearance for the FPR PHENOBARBITAL KIT, a Fluorescence Polarization Immunoassay, Phenobarbital (Class II — Special Controls, product code LGQ), submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on August 28, 1989, 39 days after receiving the submission on July 20, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number K894525 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date August 28, 1989
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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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