FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT— 510(k) K884707

Name: FDA 510(k) clearance K884707
Creator: U.S. Food and Drug Administration
Published: 1989-01-17

Substantially Equivalent

Cyberfluor, Inc.

FDA 510(k) clearance K884707 for FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT, Substantially Equivalent on 1989-01-17. Applicant: Cyberfluor, Inc.. Device class: 2.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Code LCS
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1988-11-09
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCS

view all

K922353 — DIGOXIN COATED TUBE RIA1992-08-24
K913562 — QMS - DIGOXIN1991-08-30
K895828 — INNOFLUOR DIGOXIN REAGENT SET1989-10-30
K874748 — IMMPULSE DIGOXIN ASSAY REAGENTS1988-02-19
K864802 — DART DIGOXIN ASSAY1987-02-12

More clearances from Cyberfluor, Inc.

view all

K923410 — FIAGEN PROGESTERONE1992-12-03
K905656 — FLAGEN TRIIODOTHYRONINE (T3) ASSAY1991-01-23
K904539 — FLAGEN TM FREE T41990-11-30
K900621 — FIAGEN(TM) HLH.S1990-03-01
K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-4021989-11-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.