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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K024182
Device Name PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
Applicant
PRECISION SYSTEMS, INC.
16 TECH CIRCLE
NATICK,  MA  01760
Applicant Contact BILL HADEN
Correspondent
PRECISION SYSTEMS, INC.
16 TECH CIRCLE
NATICK,  MA  01760
Correspondent Contact BILL HADEN
Regulation Number862.1770
Classification Product Code
CDQ  
Subsequent Product Codes
CEO   CGA   CGS   CGX   CHH  
CHJ   CIG   CIT   CIX   CJE   CJY  
JGJ   JGY   JJF   KNK  
Date Received12/19/2002
Decision Date 03/03/2003
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
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