Cleared Traditional

EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR

K802620 · Syva Co. · Toxicology
Oct 1980
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K802620 is an FDA 510(k) clearance for the EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR, a Calibrators, Ethyl Alcohol (Class II — Special Controls, product code DNN), submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980, 11 days after receiving the submission on October 20, 1980. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K802620 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1980
Decision Date October 31, 1980
Days to Decision 11 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

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