Cleared Traditional

ETHYL ALCOHOL CALIBRATORS & CONTROL

K924733 · Diagnostic Reagents, Inc. · Toxicology
Dec 1992
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K924733 is an FDA 510(k) clearance for the ETHYL ALCOHOL CALIBRATORS & CONTROL, a Calibrators, Ethyl Alcohol (Class II — Special Controls, product code DNN), submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 9, 1992, 78 days after receiving the submission on September 22, 1992. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K924733 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 1992
Decision Date December 09, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DNN — Calibrators, Ethyl Alcohol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200