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LCW

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Radioimmunoassay, Digitoxin (125-I)
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3300
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
MATCHED COMPONENT SET FOR DIGITOXIN (K834080)Cambridge Medical Technology1984-02-04
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT (K802461)Immunotech Corp.1980-10-31
(125 I) DIGITOXIN RIA KIT (K780766)Diagnostic Products Corp.1978-07-27

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