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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Occult Blood
510(k) Number K855237
Device Name BIOTEL (TM)/ KIDNEY
Applicant
American Diagnostic Corp.
P.O. Box 89
Wheaton,  IL  60189
Applicant Contact CRAIG BONDA
Correspondent
American Diagnostic Corp.
P.O. Box 89
Wheaton,  IL  60189
Correspondent Contact CRAIG BONDA
Regulation Number864.6550
Classification Product Code
KHE  
Date Received12/31/1985
Decision Date 05/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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