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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Atomic Absorption, Calcium
510(k) Number K914510
Device Name CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact WILLIAM T RYAN
Regulation Number862.1145
Classification Product Code
JFN  
Date Received10/09/1991
Decision Date 11/19/1991
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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