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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K955102
Device Name BIODATA TESTOSTERONE MAIA KIT
Applicant
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
100 CASCADE DR.
ALLENTOWN,  PA  18103 -9562
Applicant Contact LAURENCE A POTTER
Correspondent
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
100 CASCADE DR.
ALLENTOWN,  PA  18103 -9562
Correspondent Contact LAURENCE A POTTER
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received11/08/1995
Decision Date 06/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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