Cleared Traditional

SOPHEIA DIGOXIN EIA KIT

K832163 · Diagnostic Products Corp. · Chemistry

Aug 1983

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K832163 is an FDA 510(k) clearance for the SOPHEIA DIGOXIN EIA KIT, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPO), submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 38 days after receiving the submission on July 5, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K832163 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 1983
Decision Date	August 12, 1983
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	DPO — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3320