Astute Medical Fda Approval

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Astute Medical's NephroCheck gets FDA approval to predict risk …

https://www.medicaldevice-network.com/news/newsastute-medicals-nephrocheck-gets-fda-approval-predict-risk-acute-kidney-injury-4364750/

US-based Astute Medical has received marketing approval from the US Food and Drug Administration (FDA) for its NephroCheck test, a first-of-its-kind laboratory test to gauge severe acute kidney injury (AKI).

EVALUATION OF AUTOMATIC CLASS III …

https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN130031.pdf

The Astute Medical NEPHROCHECK® Test System is intended to be used in ... (STS) using testing methods approved by the FDA. J. Substantial E quivalence Information: 1. …

Compliance - Astute Medical

https://www.astutemedical.com/us/about/compliance/

ASTUTE MEDICAL, INC. COMPREHENSIVE COMPLIANCE PROGRAM Astute Medical, Inc. (“Astute” or the “Company”) is committed to maintaining the highest standards of …

Recently-Approved Devices | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices

You can find additional information at the links below: PMA Approvals: Monthly listings of all new or high-risk medical devices that were approved via the premarket approval (PMA) …

2020 Device Approvals | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals

Medical Devices Cleared or Approved by FDA in 2020. Device Name. Category. Date. Vercise™ PC and Vercise Gevia™ Deep Brain Stimulation (DBS) …

Astute Medical Receives FDA Clearance For …

https://www.prnewswire.com/news-releases/astute-medical-receives-fda-clearance-for-nephrocheck-test-improvements-extending-shelf-life-300282326.html

Astute Medical's NephroCheck ® Test received 510(k)-clearance through the FDA's de novo classification process in September 2014. The test was CE-marked in …

Approvals of FDA-Regulated Products | FDA - U.S. Food …

https://www.fda.gov/news-events/approvals-fda-regulated-products

Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for therapeutic purposes) Drug Approval Reports by Month. Drugs@FDA. …

Complete List of Licensed Products and Establishments

https://www.fda.gov/vaccines-blood-biologics/complete-list-licensed-products-and-establishments

Information updated monthly, and current as of December 31, 2022. List of Licensed Products and Establishments. Alphabetical List of Licensed Establishments …

Is It Really 'FDA Approved'? - U.S. Food and Drug …

https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved

The FDA approves color additives used in FDA-regulated products. This includes those used in food (including animal food), dietary supplements, drugs, …

Medtronic Sofamor Danek, USA Inc. Bhavya Vendra …

https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191066.pdf

enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic …

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