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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K935362
Device Name P-AMYLASE CONTROL
Applicant
Beckman
200 S. Kraemer Blvd.
W-337
Brea,  CA  92621
Applicant Contact DON W HART
Correspondent
Beckman
200 S. Kraemer Blvd.
W-337
Brea,  CA  92621
Correspondent Contact DON W HART
Regulation Number862.1660
Classification Product Code
JJX  
Date Received11/04/1993
Decision Date 01/27/1994
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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