Cleared Traditional

QUANTIMUNE GENTAMICIN RIA GENTAMICIN

K791770 · Bio-Rad · Toxicology
Oct 1979
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K791770 is an FDA 510(k) clearance for the QUANTIMUNE GENTAMICIN RIA GENTAMICIN, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979, 40 days after receiving the submission on September 7, 1979. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K791770 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1979
Decision Date October 17, 1979
Days to Decision 40 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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