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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 K974260
Device Name PYRILINKS-D ASSAY KIT
Applicant
Metra Biosystems, Inc.
265 N. Whisman Rd.
Mountain View,  CA  94043
Applicant Contact DAVID CASAL
Correspondent
Metra Biosystems, Inc.
265 N. Whisman Rd.
Mountain View,  CA  94043
Correspondent Contact DAVID CASAL
Regulation Number862.1400
Classification Product Code
JMM  
Date Received11/13/1997
Decision Date 01/26/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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