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DECN Subsidiary Receives 510k Submission And ''K'' Numbers from FDA CDRH for Its Genchoice! Test Strip at the Close of the Government Shutdown
DECN Subsidiary Receives 510k Submission And ''K'' Numbers from FDA CDRH for Its Genchoice! Test Strip at the Close of the Government Shutdown.
About this update from Decision Diagnostics Corp
[{"type":"text","content":"Company Also Reaches Pricing Consensus with Big Box for Private Label Version of Its Genultimate Test Strip Alleviating Remaining ObstacleLOS ANGELES, CA / ACCESSWIRE / January 30, 2018 / 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. The company's current portfolio of test strips includes its GenUltimate!, GenChoice!, GenSure!, and GenUltimate! TBG test strips, its Avantage! and Precise! Glucometers, and its PetSure! and GenUltimate! 4Pets testing products for dogs, cats and horses. Today the company announces that they have received formal FDA CDRH notification that the GenChoice! test strip 510K application submission has been accepted and routed for review. That submission has been assigned ''K'' number, K190108, which will follow the application through the review and clearance processes. This application and K number assignment, delayed by weeks due to the US government shutdown, has been released for progression. Keith Berman, CEO of DECN stated, ''Our GenChoice! 510K application is now being examined by the CDRH reviewers and investigators with whom the company has closely worked over the last eight years. Prior to this 510K submission we painstakingly examined all of our comprehensive clinical testing data, and the extensive testing protocols and results. We reached a satisfactory comfort level with the collective information; leading to the resultant application submission. The GenChoice! product clearly meets or exceeds all current FDA and ISO standards. Now that the GenChoice! is under FDA review and a ''K'' number assigned, the previously announced international GenChoice! product launch will proceed in select International markets.'' DECN simultaneously announces that discussions with the ''Big Box'' retailer for the private label manufacture of a house brand product, has progressed to the next step. The recently communicated initial pricing obstacle has been overcome and the companies are now expecting a move forwar...