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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Osteocalcin
510(k) Number K003609
Device Name N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000
Applicant
Osteometer Biotech A/S
Herlev Hovedgade 207
Herlev,  DK DK-2730
Applicant Contact PER QVIST
Correspondent
Osteometer Biotech A/S
Herlev Hovedgade 207
Herlev,  DK DK-2730
Correspondent Contact PER QVIST
Regulation Number862.1050
Classification Product Code
NEO  
Date Received11/22/2000
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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