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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K935662
Device Name SYNERMED IR 500 CHEMISTRY ANALYZER
Applicant
Synermed, Inc.
1688 50th Ave.,
Montreal (Lachine),
Quebec, Canada,  CA H8T 2V5
Applicant Contact MARCIA J ARENTZ
Correspondent
Synermed, Inc.
1688 50th Ave.,
Montreal (Lachine),
Quebec, Canada,  CA H8T 2V5
Correspondent Contact MARCIA J ARENTZ
Regulation Number862.1645
Classification Product Code
JIQ  
Subsequent Product Codes
CDQ   CEK   CEO   CFJ   CGA  
CGX   CIT   CJE   CJY   JJF  
Date Received11/26/1993
Decision Date 04/26/1994
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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