Cleared Traditional

DIGOXIN RIA KIT

K771877 · Antibodies, Inc. · Immunology
Oct 1977
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K771877 is an FDA 510(k) clearance for the DIGOXIN RIA KIT, a Radioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody Sep. (Class II — Special Controls, product code DNJ), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1977, 17 days after receiving the submission on October 4, 1977. This device falls under the Immunology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K771877 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1977
Decision Date October 21, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
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