Cleared Traditional

COAT-A-COUNT DIGOXIN RIA

K811932 · Diagnostic Products Corp. · Chemistry

Jul 1981

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K811932 is an FDA 510(k) clearance for the COAT-A-COUNT DIGOXIN RIA, 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 July 23, 1981, 17 days after receiving the submission on July 6, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K811932 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 1981
Decision Date	July 23, 1981
Days to Decision	17 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