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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 K952320
Device Name PYRILINKS-D ASSAY KIT
Applicant
Metra Biosystems, Inc.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Applicant Contact GREG SHIPPEL
Correspondent
Metra Biosystems, Inc.
14900 Sweitzer Ln.
Suite 200
Laurel,  MD  20707
Correspondent Contact GREG SHIPPEL
Regulation Number862.1400
Classification Product Code
JMM  
Date Received05/18/1995
Decision Date 12/29/1995
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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