CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name OSTEX INTERNATIONAL OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE   Document Number K011052 Analyte Name COLLAGEN TYPE I CROSSLINK, N-TELOPEPTIDES (NTX) Analyte Specialty Endocrinology Complexity WAIVED Effective Date 07/30/2001 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 south, suite 400 seattle,  WA  98134 Contact nancy js mallinak Regulation Number 862.1400 Classification Product Code JMM   Subsequent Product Code JFY   Date Received 04/06/2001 Decision Date 07/30/2001 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Clinical Chemistry Review Advisory Committee Clinical Chemistry Statement/Summary/Purged Status Summary/purged 510(k) summary summary Type Traditional Reviewed by Third Party No Expedited Review No