Cleared Traditional

GAMMA STICK 125-1 TOBRAMYCIN RIA KIT

K810011 · Alpha Gamma Laboratory · Toxicology
Jan 1981
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K810011 is an FDA 510(k) clearance for the GAMMA STICK 125-1 TOBRAMYCIN RIA KIT, a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Alpha Gamma Laboratory (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 23 days after receiving the submission on January 5, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K810011 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1981
Decision Date January 28, 1981
Days to Decision 23 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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