510(k) Premarket Notification | 合法醫療器材資訊網
1to10of27ResultsProductCode:GKZApplicant:BECKMANCOULTER,INC.DecisionDateTo:06/11/2021 ...
1 to 10 of 27 Results ProductCode: GKZ Applicant: BECKMAN COULTER, INC. Decision Date To: 06/11/2021 ...
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510(k) Premarket Notification | 合法醫療器材資訊網
1 to 10 of 27 Results ProductCode: GKZ Applicant: BECKMAN COULTER, INC. Decision Date To: 06/11/2021 ... Read More
510(k) Substantial Equivalence Determination Decision ... | 合法醫療器材資訊網
Beckman Coulter, Inc. ... for Industry and FDA Staff; March 2007 ... It is also used by Beckman Coulter manufacturing and service engineers to calibrate. Read More
Beckman Coulter Life Sciences Recalls DxH800 and DxH600 ... | 合法醫療器材資訊網
2019年5月23日 — The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Read More
Beckman Coulter's Automated Blood Banking Analyzer ... | 合法醫療器材資訊網
2020年7月22日 — Beckman Coulter's Automated Blood Banking Analyzer Receives 510(k) FDA Clearance · Offers the industry's highest throughput for a single ... Read More
Beckman Coulter's SARS | 合法醫療器材資訊網
2021年3月23日 — Beckman Coulter also recently launched an automated SARS-CoV-2 antigen test in the U.S. under Policy C of the FDA's emergency use ... Read More
Establishment Registration & Device Listing | 合法醫療器材資訊網
Results 1 - 10 of 22 — FDA, U.S. Food and Drug Administration ... Show all 6 Listings for Beckman Coulter Biomedical GmbH15 GERMANY ... Coulter Diff AcT Pak Reagent Kit (PN 8448344); COULTER DxH Cell Lyse; COULTER HmX PAK ... Read More
FDA alerts hospitals | 合法醫療器材資訊網
2019年5月23日 — The recall is related to the devices' platelet analyzing function. Beckman Coulter has not received complaints that this issue impacts other ... Read More
Premarket Approval (PMA) | 合法醫療器材資訊網
FDA, U.S. Food and Drug Administration. U.S. Food & Drug Administration ... 1 to 10 of 18 Results Applicant BECKMAN COULTER, INC. productcode LTJ ... Read More
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