Cleared Traditional

AMIKACIN ANALYTICAL TEST PACK ACA

K843211 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Sep 1984
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K843211 is an FDA 510(k) clearance for the AMIKACIN ANALYTICAL TEST PACK ACA, a Radioimmunoassay, Amikacin (Class II — Special Controls, product code KLQ), submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984, 28 days after receiving the submission on August 15, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3035.

Submission Details

510(k) Number K843211 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1984
Decision Date September 12, 1984
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KLQ — Radioimmunoassay, Amikacin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3035

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