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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Digitoxin (125-I)
510(k) Number K802461
Device Name ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
Applicant
Immunotech Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Immunotech Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.3300
Classification Product Code
LCW  
Date Received10/08/1980
Decision Date 10/31/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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