Cleared Traditional

OPUS DIGITOXIN

K935229 · Pb Diagnostic Systems, Inc. · Toxicology
Dec 1993
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K935229 is an FDA 510(k) clearance for the OPUS DIGITOXIN, a Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPG), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on December 22, 1993, 51 days after receiving the submission on November 1, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3300.

Submission Details

510(k) Number K935229 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1993
Decision Date December 22, 1993
Days to Decision 51 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

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