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DPO — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. Class II

FDA Device Classification

Classification Details

Product Code
DPO
Device Class
Class II
Regulation Number
862.3320
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914833cirrus diagnosticsIMMULITE DIGOXINNovember 22, 1991
K905719biotopeECLIPSE ICA DIGOXINJanuary 17, 1991
K864449canadian bioclinicalDIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITFebruary 2, 1987
K833842immuno assayRIA COAT DIGOXINJanuary 17, 1984
K832163diagnostic productsSOPHEIA DIGOXIN EIA KITAugust 12, 1983
K830962immuchemIMMUCHEM COVALENT-COAT RIA KITMay 4, 1983
K811932diagnostic productsCOAT-A-COUNT DIGOXIN RIAJuly 23, 1981
K811776kallestad laboratoriesKALLESTAD QUANTICOAT 125 DIGOXINJuly 10, 1981
K800205boehringer mannheimRIA PHASE DIGOXINMarch 19, 1980
K791325micromedic systemsAUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEMAugust 16, 1979
K791355ventrex laboratoriesVENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KITAugust 10, 1979
K771638bd becton dickinson vacutainer systems preanalyticIGOXIN SOLID PHASE RIAOctober 7, 1977
K770365travenol laboratoriesRADIOIMMUNOASSAY DIGOXIN TEST, IN VITROFebruary 24, 1977
K770069e. r. squibb and sonsDIGOXIN CLASP TM RIA KITJanuary 18, 1977