Cleared Traditional

IL TOBRAMYCIN ASSAY

K903192 · Instrumentation Laboratory CO · Chemistry
Aug 1990
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K903192 is an FDA 510(k) clearance for the IL TOBRAMYCIN ASSAY, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 22, 1990, 34 days after receiving the submission on July 19, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K903192 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1990
Decision Date August 22, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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