Cleared Traditional

FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT

K884707 · Cyberfluor, Inc. · Chemistry
Jan 1989
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K884707 is an FDA 510(k) clearance for the FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT, a Radioimmunoassay, Digoxin (125-i) (Class II — Special Controls, product code LCS), submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on January 17, 1989, 69 days after receiving the submission on November 9, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K884707 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1988
Decision Date January 17, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LCS — Radioimmunoassay, Digoxin (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320