Cleared Traditional

RABBIT ANTIBODY TO DIGOXIN

K780316 · Pcl-Ria, Inc. · Toxicology
Mar 1978
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K780316 is an FDA 510(k) clearance for the RABBIT ANTIBODY TO DIGOXIN, a Antiserum, Digoxin (Class II — Special Controls, product code DKA), submitted by Pcl-Ria, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978, 21 days after receiving the submission on February 24, 1978. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K780316 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1978
Decision Date March 17, 1978
Days to Decision 21 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