DELFIA DIGOXIN— 510(k) K861195

Substantially Equivalent

Lkb Instruments, Inc.

FDA 510(k) clearance K861195 for DELFIA DIGOXIN, Substantially Equivalent on 1986-07-11. Applicant: Lkb Instruments, Inc.. Device class: 2.

Clearance details

Applicant
Lkb Instruments, Inc.
Product code
Code KXT
Device class
Class 2
Regulation
21 CFR 862.3320
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Gaithersburg, MD, US
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