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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 K191454
Device Name Atellica CH Amylase_2 (AMY_2)
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr. P.O. Box 6101. M/S 514
Newark,  DE  19714
Applicant Contact Catherine Daigle
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr. P.O. Box 6101. M/S 514
Newark,  DE  19714
Correspondent Contact Catherine Daigle
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received05/31/2019
Decision Date 07/30/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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