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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 K971312
Device Name IMMULITE PYRILINKS-D
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number862.1400
Classification Product Code
JMM  
Date Received04/09/1997
Decision Date 05/27/1997
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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