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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K013654
Device Name PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
Applicant
Precision Systems, Inc.
16 Tech Cir.
Natick,  MA  01760
Applicant Contact BILL HADEN
Correspondent
Precision Systems, Inc.
16 Tech Cir.
Natick,  MA  01760
Correspondent Contact BILL HADEN
Regulation Number862.2170
Classification Product Code
JJF  
Subsequent Product Codes
CDQ   CEK   CEO   CFJ   CFM  
CGA   CHG   CHH   CIG   CIT   CIX  
CJE   CJY   CKA   GGX   JFJ   JGJ  
JGY   JMO   JQB   KHS   KNK   LBR  
Date Received11/06/2001
Decision Date 06/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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