Cleared Traditional

TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD

K893913 · Technicon Instruments Corp. · Toxicology
Aug 1989
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K893913 is an FDA 510(k) clearance for the TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on August 21, 1989, 83 days after receiving the submission on May 30, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K893913 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 1989
Decision Date August 21, 1989
Days to Decision 83 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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