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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Column Chromatography & Color Development, Hydroxyproline
510(k) Number K011052
Device Name OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
Applicant
Ostex Intl., Inc.
2203 Airport Way S.
Suite 400
Seattle,  WA  98134
Applicant Contact NANCY JS MALLINAK
Correspondent
Ostex Intl., Inc.
2203 Airport Way S.
Suite 400
Seattle,  WA  98134
Correspondent Contact NANCY JS MALLINAK
Regulation Number862.1400
Classification Product Code
JMM  
Subsequent Product Code
JFY  
Date Received04/06/2001
Decision Date 07/30/2001
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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