P090026 - Premarket Approval (PMA) - FDA

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

Device	ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
Generic Name	P2psa
Applicant	Beckman Coulter, Inc.1000 Lake Hazeltine Dr.Chaska, MN 55318
PMA Number	P090026
Date Received	11/17/2009
Decision Date	06/14/2012
Product Code	OYA
Docket Number	12M-0638
Notice Date	06/20/2012
Advisory Committee	Immunology
Expedited Review Granted?	No
Combination Product	No
Predetermined Change Control Plan Authorized	No
Recalls	CDRH Recalls
Approval Order Statement APPROVAL FOR THE ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS. THIS DEVICE IS INDICATED FOR: THE ACCESS HYBRITECH P2PSA ASSAY IS A PARAMAGNETIC PARTICLE, CHEMILUMINESCENT IMMUNOASSAY FOR THE QUANTITATIVE DETERMINATION OF [-2]PROPSA ANTIGEN, AN ISOFORM OF FREEPSA, IN HUMAN SERUM USING THE ACCESS IMMUNOASSAY SYSTEMS. ACCESS HYBRITECH P2PSA IS INTENDED TO BE USED IN COMBINATION WITH ACCESS HYBRITECH (TOTAL) PSA AND ACCESS HYBRITECH FREE PSA TO CALCULATE THE BECKMAN COULTER PROSTATE HEALTH INDEX (PHI), AN IN VITRO DIAGNOSTIC MULTIVARIATE INDEX ASSAY (IVDMIA). BECKMAN COULTER PHI AS CALCULATED USING THE ACCESS HYBRITECH ASSAYS IS INDICATED FOR USE ASAN AID IN DISTINGUISHING PROSTATE CANCER FROM BENIGN PROSTATIC CONDITIONS, FOR PROSTATE CANCER DETECTION IN MEN AGED 50 YEARS AND OLDER WITH TOTAL PSA >= 4.0 TO Từ khóa » Phi Fda FDA Phi Sciences MARCS-CMS 566043 — January 30, 2019 - FDA [PDF] Chapter 2 – FDA Authority August 2018 Regulations: Good Clinical Practice And Clinical Trials - FDA HIPAA Compliance For Reporters To FDA MedWatch What Health Information Is Protected By The Privacy Rule? The Prostate Health Index: Its Utility In Prostate Cancer Detection 'Extreme Disappointment': With FDA Snub Of Akebia's Vadadustat ... Prostate Health Index (phi) - Beckman Coulter Medical Device HIPAA Compliance: Sharing Patient Information Public Health FDA Clears Beckman Coulter's Phi Blood Test For Prostate Cancer FDA Accepts Application For GSK's Chronic Kidney Disease Drug HIPAA & PHI: Institutional Review Board (IRB) Office Liên Hệ TRUYỀN HÌNH CÁP SÔNG THU ĐÀ NẴNG Địa Chỉ: 58 Hàm Nghi - Đà Nẵng Phone: 0905 989 xxx Web: truyenhinhcapsongthu.net Facebook: https://fb.com/truyenhinhcapsongthu/ Twitter: @ Capsongthu Copyright © 2022 \| Thiết Kế Truyền Hình Cáp Sông Thu

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