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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
510(k) Number K895850
Device Name SYNCHRON CX SYSTEMS (LAP) REAGENT KIT
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 Number862.1460
Classification Product Code
JGG  
Date Received10/03/1989
Decision Date 12/05/1989
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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