Cleared Traditional

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD

K904304 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology
Oct 1990
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K904304 is an FDA 510(k) clearance for the DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on October 26, 1990, 37 days after receiving the submission on September 19, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K904304 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1990
Decision Date October 26, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLB — Radioimmunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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