Atlas FDA

DPO

14 FDA 510(k) clearances · Product code

35 daysmedian time to decision
75 days90th percentile
14clearances measured

FDA profile

Official device name
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube 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
IMMULITE DIGOXIN (K914833)Cirrus Diagnostics, Inc.1991-11-22
ECLIPSE ICA DIGOXIN (K905719)Biotope, Inc.1991-01-17
DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K864449)Canadian Bioclinical, Ltd.1987-02-02
RIA COAT DIGOXIN (K833842)Immuno Assay Corp.1984-01-17
SOPHEIA DIGOXIN EIA KIT (K832163)Diagnostic Products Corp.1983-08-12
IMMUCHEM COVALENT-COAT RIA KIT (K830962)Immuchem Corp.1983-05-04
COAT-A-COUNT DIGOXIN RIA (K811932)Diagnostic Products Corp.1981-07-23
KALLESTAD QUANTICOAT 125 DIGOXIN (K811776)Kallestad Laboratories, Inc.1981-07-10
RIA PHASE DIGOXIN (K800205)Boehringer Mannheim Corp.1980-03-19
AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM (K791325)Micromedic Systems1979-08-16
VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT (K791355)Ventrex Laboratories, Inc.1979-08-10
IGOXIN SOLID PHASE RIA (K771638)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-10-07
RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO (K770365)Travenol Laboratories, S.A.1977-02-24
DIGOXIN CLASP TM RIA KIT (K770069)E. R. Squibb & Sons, Inc.1977-01-18

Track DPO automatically

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