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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 K964889
Device Name ELECSYS TESTOSTERONE ASSAY
Applicant
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
P.O. BOX 4117
CONCORD,  CA  94524 -4117
Applicant Contact YVETTE LLODY
Correspondent
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
P.O. BOX 4117
CONCORD,  CA  94524 -4117
Correspondent Contact YVETTE LLODY
Regulation Number862.1680
Classification Product Code
CDZ  
Subsequent Product Code
JIT  
Date Received12/06/1996
Decision Date 03/18/1997
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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