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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 K800921
Device Name NORDICLAB TESTOSTERONE RIA TEST
Applicant
NORDICLAB INTL.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NORDICLAB INTL.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received04/21/1980
Decision Date 05/14/1980
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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