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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 K052649
Device Name DRG SLV TESTOSTERONE ELISA TEST
Applicant
Drg Intl., Inc.
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Drg Intl., Inc.
150 Cherry Lane Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received09/26/2005
Decision Date 01/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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