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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 (photometric, discrete), for clinical use
510(k) Number K965240
Device Name SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA,  CA  92821 -6208
Applicant Contact SHERI HALL
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD.
W-337
BREA,  CA  92821 -6208
Correspondent Contact SHERI HALL
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CDS   CEK   CEM   CEO   CGA  
CGX   CGZ   CIX   JFL   JFP   JGS  
JIX  
Date Received12/30/1996
Decision Date 03/10/1997
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
Recalls CDRH Recalls
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