OpGen Completes Clinical Trials for its Initial FDA 510(k) Submission
OpGen, Inc. (OPGN)
Last opgen, inc. earnings: 11/6 04:05 pm
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Source: GlobeNewswire
GAITHERSBURG, Md., Feb. 05, 2019 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN) announced today that it has completed the clinical trials needed to support its 510(k) submission for the detection of antimicrobial resistance genes in bacterial isolates to the U.S. Food & Drug Administration (“FDA”) for clearance of its Acuitas® AMR Gene Panel u5.47 product. The clinical trials tested more than 1,000 clinical isolates at four participating clinical sites: The Johns Hopkins University School of Medicine; Wadsworth Center, New York State Department of Health; University Hospitals Cleveland Medical Center; and IHMA, Inc. The company has completed the majority of analytical testing activities including reproducibility studies and DNA sequencing of over 1,000 isolates to support the planned 510(k) submission. “We are pleased to have completed the isolate clinical trials as an important milestone toward submission for FDA clearance of our Acuitas AMR Gene Panel u5.47 product. We are encou
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News
- OpGen Receives Nasdaq Notice Regarding Delayed Form 10-K [Yahoo! Finance]Yahoo! Finance
- OpGen Receives Nasdaq Notice Regarding Delayed Form 10-KGlobeNewswire
- OpGen, Inc. (NASDAQ: OPGN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- OpGen, Inc. (NASDAQ: OPGN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- OpGen, Inc. (NASDAQ: OPGN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
OPGN
Earnings
- 11/14/23 - Miss
OPGN
Sec Filings
- 4/25/24 - Form SC
- 4/25/24 - Form 4
- 4/25/24 - Form 8-K
- OPGN's page on the SEC website