Cleared Traditional

K771533 - DIGOXIN RIA KIT
(FDA 510(k) Clearance)

K771533 · G.D. Searle and Co. · Toxicology device
Aug 1977
Decision
15d
Days
Class 2
Risk

K771533 is an FDA 510(k) clearance for the DIGOXIN RIA KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody Sep. (Class II - Special Controls, product code DNJ).

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1977, 15 days after receiving the submission on August 10, 1977.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K771533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1977
Decision Date August 25, 1977
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DNJ — Radioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody Sep.
Device Class Class II - Special Controls
CFR Regulation 21 CFR 862.3320