Cleared Traditional

GENTAMICIN TEST PACK-ACA

K831210 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
May 1983
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K831210 is an FDA 510(k) clearance for the GENTAMICIN TEST PACK-ACA, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983, 41 days after receiving the submission on April 14, 1983. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K831210 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 1983
Decision Date May 25, 1983
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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