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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 K881495
Device Name SYNCHRON CX(TM)5 CLINICAL ANALYZER
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact WILLIAM T RYAN
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Correspondent Contact WILLIAM T RYAN
Regulation Number862.2160
Classification Product Code
JJE  
Date Received04/08/1988
Decision Date 06/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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