Cleared Traditional

INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS

K792469 · Intersci Corp. · Toxicology
Jan 1980
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K792469 is an FDA 510(k) clearance for the INTERSCI TEST FOR ALCOHOL IN BODY FLUIDS, a Potassium Dichromate, Alcohol (Class II — Special Controls, product code DOJ), submitted by Intersci Corp. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980, 51 days after receiving the submission on December 3, 1979. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3040.

Submission Details

510(k) Number K792469 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 1979
Decision Date January 23, 1980
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DOJ — Potassium Dichromate, Alcohol
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3040