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In Prelude to Probable Transaction DECN Decides to Infuse its Outre' Precise, TBG Technology to its GenChoice Test Strip, Now in FDA 510k Review
In Prelude to Probable Transaction DECN Decides to Infuse its Outre' Precise, TBG Technology to its GenChoice Test Strip, Now in FDA 510k Review.
About this update from Decision Diagnostics Corp
[{"type":"text","content":" Company Also Plans 3Q 2019 Filing of Four Patents Covering GenUltimate TBG and GenChoice TBG SystemsLOS ANGELES, CA / ACCESSWIRE / April 23, 2019 / Decision Diagnostics Corp. (OTC PINK: DECN) Decision Diagnostics Corp. is a 17 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 a growing brand of glucose test strips and meters as highly accurate alternatives for legacy diabetic, proprietary, and pet testing glucose test strips.Decision Diagnostics is pleased to announce that its Korean R&D group in conjunction with CEO Keith Berman and his Stoney Fork new products experts have designed a method and determined meter specifics for the adding of the company's TBG technology to the upcoming GenChoice test strip now in FDA 510K review. Development of this newer version of the already new GenChoice test strip will be six months from the engineering feasibility to the filing of the 510K with the U.S. FDA.Keith Berman, CEO of DECN commented, ''Our Korean partners approached us some five weeks ago and told us of their concept. I then asked my advanced development consultants to prepare the first engineering diagrams. Although the chemistries are different between GenUltimate and GenChoice, it became irresistible, and thus we have added the TBG features to our GenChoice tool box. The performance of the GenChoice TBG is expected to be at the +/- 7.5% level 97 or 98% of the time.''The company's current portfolio of test strips includes its market established GenUltimate! and GenSure! test strips (for international use), plus the upcoming GenChoice!, and the outre' precise GenUltimate! TBG, GenPrecis! and now the GenChoice TBG systems (strip and meter). GenChoice, GenPrecis, and GenUltimate TBG are currently in one of regulatory review, clinical trials or advanced development. The company has also added the Avantage!, Precise! and Re'al! glucometers to its product lines. DECN is also involved in the pet testing markets with their PetSure! and GenUltimate! 4Pets testing products for dogs, cats and horses.Mr. Berman continued, ''In addition to the new product entries, which are certainly exciting and company building, we also plan to file four patent applications in 3Q 201...