Cleared Traditional

DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

K864449 · Canadian Bioclinical, Ltd. · Chemistry
Feb 1987
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K864449 is an FDA 510(k) clearance for the DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPO), submitted by Canadian Bioclinical, Ltd. (Ontario Mix 1b4, CA). The FDA issued a Cleared decision on February 2, 1987, 82 days after receiving the submission on November 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K864449 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1986
Decision Date February 02, 1987
Days to Decision 82 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