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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission
510(k) Number K192271
Device Name Access PCT, Access PCT Calibrators
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Applicant Contact Jennifer Bennett
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318
Correspondent Contact Jennifer Bennett
Regulation Number866.3215
Classification Product Code
PTF  
Date Received08/22/2019
Decision Date 11/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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