Cleared Traditional

COAT-A-COUNT DIGITOXIN RIA KIT

K812129 · Diagnostic Products Corp. · Toxicology
Aug 1981
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K812129 is an FDA 510(k) clearance for the COAT-A-COUNT DIGITOXIN RIA KIT, a Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPG), submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 17 days after receiving the submission on July 27, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3300.

Submission Details

510(k) Number K812129 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1981
Decision Date August 13, 1981
Days to Decision 17 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