OpGen has announced that it has filed for 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates with the FDA, with clearance expected by the end of the year. The company continues to expect to file a follow-on De Novo 510(k) submission in Q419 for approval of the Acuitas AMR Gene Panel test in urine samples, with another De Novo 510(k) submission for the Acuitas Lighthouse software soon thereafter or at approximately the same time.
20 May 2019
OpGen - First 510(k) filed with the FDA
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OpGen - First 510(k) filed with the FDA
OpGen has announced that it has filed for 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates with the FDA, with clearance expected by the end of the year. The company continues to expect to file a follow-on De Novo 510(k) submission in Q419 for approval of the Acuitas AMR Gene Panel test in urine samples, with another De Novo 510(k) submission for the Acuitas Lighthouse software soon thereafter or at approximately the same time.