Cleared Traditional

AMES TDA PRIMIDONE TEST

K802654 · Miles Laboratories, Inc. · Toxicology
Nov 1980
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K802654 is an FDA 510(k) clearance for the AMES TDA PRIMIDONE TEST, a Enzyme Immunoassay, Primidone (Class II — Special Controls, product code DJD), submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on November 12, 1980, 19 days after receiving the submission on October 24, 1980. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3680.

Submission Details

510(k) Number K802654 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1980
Decision Date November 12, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DJD — Enzyme Immunoassay, Primidone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3680