Cleared Traditional

K780498 - CBR-DIGOXIN ANTISERUM
(FDA 510(k) Clearance)

K780498 · Clinical Bioresearch · Toxicology
Apr 1978
Decision
8d
Days
Class 2
Risk

K780498 is an FDA 510(k) clearance for the CBR-DIGOXIN ANTISERUM, a Antiserum, Digoxin (Class II — Special Controls, product code DKA), submitted by Clinical Bioresearch (Mchenry, US). The FDA issued a Cleared decision on April 5, 1978, 8 days after receiving the submission on March 28, 1978. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K780498 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1978
Decision Date April 05, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DKA — Antiserum, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320