Cleared Traditional

K944932 - PHENOBARBITAL FLEX REAGENT CARTRIDGE
(FDA 510(k) Clearance)

K944932 · Dupont Medical Products · Toxicology

Dec 1994

Decision

83d

Days

Class 2

Risk

K944932 is an FDA 510(k) clearance for the PHENOBARBITAL FLEX REAGENT CARTRIDGE. This device is classified as a Enzyme Immunoassay, Phenobarbital (Class II — Special Controls, product code DLZ).

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on December 28, 1994, 83 days after receiving the submission on October 6, 1994.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3660.

Submission Details

510(k) Number	K944932 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 06, 1994
Decision Date	December 28, 1994
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF