Atlas FDA

DKP

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Radioimmunoassay, Phenobarbital
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3660
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT (K844167)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-11-27
FLUOROMATIC PHENOLBARBITAL FIA (K800090)Bio-Rad1980-01-23
IN VITRO PHENOBARBITAL RIA TEST (K772111)Clinical Assays, Inc.1977-11-28

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