Cleared Traditional

RIALYZE DIGOXIN

K780075 · Miles Laboratories, Inc. · Toxicology
Feb 1978
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K780075 is an FDA 510(k) clearance for the RIALYZE DIGOXIN, a Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPG), submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978, 43 days after receiving the submission on January 16, 1978. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3300.

Submission Details

510(k) Number K780075 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 1978
Decision Date February 28, 1978
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DPG — Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3300