Cleared Traditional

ETHYL ALCOHOL SERUM CALIBRATOR

K810466 · Syva Co. · Toxicology
Mar 1981
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K810466 is an FDA 510(k) clearance for the ETHYL ALCOHOL SERUM 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 March 6, 1981, 11 days after receiving the submission on February 23, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K810466 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 1981
Decision Date March 06, 1981
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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