Astute Medical Fda

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EVALUATION OF AUTOMATIC …

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

Astute Medical Receives FDA Clearance for …

https://www.genomeweb.com/proteomics/astute-medical-receives-fda-clearance-nephrocheck-test-begins-prepping-us-launch

Astute last month entered into a sales and licensing agreement with OCD under which Astute made the company the exclusive sales agent for NephroCheck and …

bioMérieux reinforces its offering of High Medical Value …

https://www.biomerieux.com/corp/en/journalists/press-releases/biomerieux-reinforces-its-offering-high-medical-value-immunoassay-biomarkers-acquisition-astute.html

bioMérieux, a world leader in the field of in vitro diagnostics, announces today the acquisition of Astute Medical Inc., a company dedicated to improving the diagnosis of …

Astute Medical Inc FDA Filings

https://fda.report/Company/Astute-Medical-Inc

This page includes the latest FDA filings for Astute Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo …

Compliance - Astute Medical

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

Astute Medical, Inc. (“Astute” or the “Company”) is committed to maintaining the highest standards of corporate conduct and ethics. Accordingly, Astute has adopted this …

510(k) Premarket Notification - accessdata.fda.gov

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K191066

CD Horizon™ Astute™ Spinal System: Applicant: Medtronic Sofamor Danek, USA Inc. ... Regulation Medical Specialty: ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) …

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

SAN DIEGO, June 9, 2016 /PRNewswire/ -- Astute Medical, Inc., developer of biomarkers for better healthcare, today announced that it has received U.S. Food and …

FDA nod triggers $30m milestone for Astute Medical

https://www.massdevice.com/fda-nod-triggers-30m-milestone-astute-medical/

Last month, San Diego-based Astute won 510 (k) clearance for NephroCheck, which is used to test for acute kidney injury, or AKI, in patients who have recently suffered a …

Class 2 Device Recall ASTUTE REAGENT

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=197146

ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013: Code Information: UDI/DI 03573026565503, Batch Numbers: 22LCK0024G Recalling …

Astute Medical Gains FDA Clearance for NephroCheck Test

https://www.fdanews.com/articles/176983-astute-medical-gains-fda-clearance-for-nephrocheck-test

Astute Medical Gains FDA Clearance for NephroCheck Test June 9, 2016 Astute Medical has secured FDA clearance for updates to its NephroCheck test kit, which is intended for the risk assessment for moderate or severe acute kidney injury. The clearance prolongs the shelf life for the test to 12 months when refrigerated.

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