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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
Original Applicant
BECKMAN INSTRUMENTS, INC.
200 south kraemer blvd.
m.s. w-351
brea,  CA  92621
Original 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
Recalls CDRH Recalls
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