Cleared Traditional

GENTAMICIN RIA KIT

K780516 · Antibodies, Inc. · Immunology
Apr 1978
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K780516 is an FDA 510(k) clearance for the GENTAMICIN RIA KIT, a Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (Class II — Special Controls, product code DJB), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978, 29 days after receiving the submission on March 30, 1978. This device falls under the Immunology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K780516 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1978
Decision Date April 28, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
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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