Cleared Traditional

GAMMA STICK GENTAMICIN RIA KIT

K800537 · Alpha Gamma Laboratory · Toxicology
Apr 1980
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K800537 is an FDA 510(k) clearance for the GAMMA STICK GENTAMICIN RIA KIT, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Alpha Gamma Laboratory (Mchenry, US). The FDA issued a Cleared decision on April 24, 1980, 45 days after receiving the submission on March 10, 1980. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K800537 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1980
Decision Date April 24, 1980
Days to Decision 45 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DJB — Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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