Cleared Traditional

ULTRA-DIG

K812749 · Antibodies, Inc. · Toxicology
Oct 1981
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K812749 is an FDA 510(k) clearance for the ULTRA-DIG, a Radioimmunoassay, Digoxin (125-i) (Class II — Special Controls, product code LCS), submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981, 20 days after receiving the submission on September 29, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K812749 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1981
Decision Date October 19, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCS — Radioimmunoassay, Digoxin (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320