Cleared Traditional

K864802 - DART DIGOXIN ASSAY
(FDA 510(k) Clearance)

K864802 · Coulter Electronics, Inc. · Chemistry device

Feb 1987

Decision

65d

Days

Class 2

Risk

K864802 is an FDA 510(k) clearance for the DART DIGOXIN ASSAY. This device is classified as a Radioimmunoassay, Digoxin (125-i) (Class II - Special Controls, product code LCS).

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on February 12, 1987, 65 days after receiving the submission on December 9, 1986.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K864802 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 09, 1986
Decision Date	February 12, 1987
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—