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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase-Esterase, Enzymatic, Photometric, Lipase
510(k) Number K952180
Device Name CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
Applicant
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Applicant Contact DON W HART
Correspondent
BECKMAN INSTRUMENTS, INC.
200 SOUTH KRAEMER BLVD., W-337
BOX 8000
BREA,  CA  92622 -8000
Correspondent Contact DON W HART
Regulation Number862.1465
Classification Product Code
CHI  
Date Received05/09/1995
Decision Date 08/17/1995
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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