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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 K000043
Device Name DRG AURICA ELISA TESTOSTERONE KIT
Applicant
DRG INTL., INC.
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301
Applicant Contact NIKOLAS BUTKOV
Correspondent
DRG INTL., INC.
150 CHERRY LANE RD.
EAST STROUDSBURG,  PA  18301
Correspondent Contact NIKOLAS BUTKOV
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received01/06/2000
Decision Date 04/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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