Atlas FDA

DON

17 FDA 510(k) clearances · Product code

33 daysmedian time to decision
74 days90th percentile
17clearances measured

FDA profile

Official device name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3320
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
CIBA CORNING ACS DIGOXIN IMMUNOASSAY (K902861)Ciba Corning Diagnostics Corp.1990-09-10
CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY (K881679)Ciba Corning Diagnostics Corp.1988-07-08
MAGIC 125I DIGOXIN RADIOIMMUNOASSAY (K840461)Corning Medical & Scientific1984-03-23
PHASE II DIGOXIN RADIOIMMUNOASSAY KIT (K830533)Medical & Scientific Designs, Inc.1983-04-05
ZETAPHASE-DIG (K822053)Biological & Diagnostic Products1982-07-27
ENZYMUNE-TEST DIGOXIN (K821000)Icl Scientific1982-04-26
DIGOXIN RIA ASSAY (K810296)Ria Diagnostics1981-02-19
DIGOXIN RIABEAD DIAGNOSTIC KIT (K803075)Abbott Laboratories1980-12-22
TECHNICON STAR SYSTEM (K791549)Technicon Instruments Corp.1979-09-27
RIA, DIGOXIN (K781660)E. R. Squibb & Sons, Inc.1978-10-24
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (K780475)Burroughs Wellcome Co.1978-04-24
LIQUISOL DIGOXIN RIA TEST KIT (K780207)Damon Corp.1978-02-23
QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA (K772422)Bio-Rad1978-02-13
DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS (K772098)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-12-20
CEBTRIA DIGOXIN RIA (K771255)Union Carbide Corp.1977-08-25
CAMMADISK DIGOXIN (K770269)Burroughs Wellcome Co.1977-03-16
SPAC DIGOXIN KIT (K760800)Mallinckrodt Critical Care1976-11-01

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