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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K934293
Device Name BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Correspondent Contact WILLIAM T RYAN
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received09/02/1993
Decision Date 07/06/1994
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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