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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 K970905
Device Name SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
M.S. W-351
Brea,  CA  92621
Applicant Contact SHERI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
M.S. W-351
Brea,  CA  92621
Correspondent Contact SHERI HALL
Regulation Number862.1465
Classification Product Code
CHI  
Subsequent Product Code
JIT  
Date Received03/12/1997
Decision Date 06/04/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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