Cleared Traditional

TOBRAMYCIN RIA KIT

K800743 · Antibodies, Inc. · Toxicology
Apr 1980
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K800743 is an FDA 510(k) clearance for the TOBRAMYCIN RIA KIT, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980, 13 days after receiving the submission on April 3, 1980. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K800743 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1980
Decision Date April 16, 1980
Days to Decision 13 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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