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DECN Receives Completed Clinical Trials Report from its IRB and Anticipates Filing its U.S. FDA 510k Application for its Genchoice! Product on December 21, 2018
DECN Receives Completed Clinical Trials Report from its IRB and Anticipates Filing its U.S. FDA 510k Application for its Genchoice! Product on December 21, 2018.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"DECN to Launch Genchoice! Product in Select International Markets January 2, 2019 and to File gor CE Mark in the EU and Health Canada Approval in Early 2019LOS ANGELES, CA / ACCESSWIRE / December 4, 2018 / Decision Diagnostics Corp. (OTC PINK: DECN) is a 16 year old, diabetes-focused bio-technology R&D firm, manufacturer, quality plan administrator, FDA registered medical device customer support organization, and exclusive worldwide sales and regulatory process agent for the GenUltimate! ("Sunshine") diabetes test strip, the internationally launched GenSure! ("Feather") diabetes test strip, and the GenChoice! ("Ladybug") which is now in the process of completing its 510K application for filing with the U.S. FDA, the market ready PetSure! test strip for the diabetic testing of dogs and cats, the market ready GenUltimate! 4Pets system (new) also for the diabetic testing of dogs and cats, and the panacea GenPrecis! ("Dragonfly") diabetes testing system, ready for clinical trials.Keith Berman, CEO of Decision Diagnostics stated, ''The receipt of the completed report from the company's IRB is an important event for the company. It indicates that we have reached a milestone for our GenChoice! product where we now have proven technology that meets or exceeds all FDA and ISO (international) standards. We anticipate filing the 510K application with the FDA for their review on December 21, 2018.''Mr. Berman continued, ''We view GenChoice! as the first necessary advance of our business model where our ''Gen'' brand will become the low priced but high quality alternative for a number of legacy glucose test strips. GenChoice is the second of four anticipated alternative test strips for the legacy systems that account for approximately 71% of the U.S. market, and at even higher levels in the EU. We plan to launch GenChoice! in select International markets on January 2, 2019. We will update our web sites with images of the GenChoice! international packaging in the next several weeks.''Mr. Berman concluded, ''In the next 10 days, we also intend to discuss a major advance to our GenPrecis! test strip and meter, allowing us, hopefully, to shorten the time for U.S. FDA clearance which will evolve our panacea product to become a savior product for one of the legacy system companies. Please stay tuned for ...