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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K991917
Device Name OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
Applicant
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085
Applicant Contact YA-CHEN HSU
Correspondent
Metrika, Inc.
510 Oakmead Pkwy.
Sunnyvale,  CA  94085
Correspondent Contact YA-CHEN HSU
Regulation Number862.1660
Classification Product Code
JJW  
Date Received06/07/1999
Decision Date 07/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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