Atlas FDA

DMP

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Digoxin Control Serum, Ria
Device class
Class I (low risk)
Regulation
21 CFR 862.3280
Medical specialty
Clinical Toxicology
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RecordFirmDate
ELECSYS CALLCHECK DIGOXIN (K973973)Boehringer Mannheim Corp.1997-11-04
TOX PERFECT A TUBE (K953393)Chimera Research & Chemical, Inc.1995-10-06
DIGOXIN STANDARDS IN HUMAN SERUM (K780889)Pcl-Ria, Inc.1978-08-14
DIGI TROL TM-RX & DIGI TROL TM-TX (K770411)Nuclear Medical Laboratories, Inc.1977-03-16

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Every clearance here is in the API, with alerts when new ones post.