Cleared Traditional

ALCOHOL CALIBRATORS

K853532 · Diagnostic Systems · Chemistry
Sep 1985
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K853532 is an FDA 510(k) clearance for the ALCOHOL CALIBRATORS, a Calibrators, Ethyl Alcohol (Class II — Special Controls, product code DNN), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on September 16, 1985, 24 days after receiving the submission on August 23, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K853532 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1985
Decision Date September 16, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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