Cleared Traditional

IN-VITRO TEST DETERMINATION OF TOBRAMYCIN

K854184 · Clinical Data, Inc. · Toxicology
Dec 1985
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K854184 is an FDA 510(k) clearance for the IN-VITRO TEST DETERMINATION OF TOBRAMYCIN, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on December 4, 1985, 50 days after receiving the submission on October 15, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K854184 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1985
Decision Date December 04, 1985
Days to Decision 50 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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