New update on FDA status......US, Korea, Australia
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Posted On: 12/18/2017 5:09:56 PM
New update on FDA status......US, Korea, Australia bodes well for this little soon to be big GEM! Closed at .58 last pps .658
United Health Products Completes Multiple FDA Required Tests for HemoStyp(R)Font size: A | A | A
8:30 AM ET 12/18/17 | GlobeNewswire
United Health Products Completes Multiple FDA Required Tests for HemoStyp(R)
Will Apply for South Korea MFDS Classification
HENDERSON, Nev., Dec. 18, 2017 (GLOBE NEWSWIRE) -- United Health Products, Inc. (UHP) (OTC:UEEC), manufacturer and marketer of HemoStyp, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that it has completed an array of tests required as a part of a FDA submission. The biocompatibility tests, which were conducted at independent laboratories Nelson Labs and EMSL Analytical, tested for irritability, sensitivity, cytoxcity, and absorption of the company's HemoStyp product. Results from the tests exceeded the performance of any competitive products known to the company. The results will be published on the company's website following presentation to the FDA and other international regulatory agencies in Australia and South Korea.
Separately, UHP is pleased to announce that its South Korean distribution partner in South Korea has prepared a submission for HemoStyp with the South Korean Ministry of Food and Drug Safety (MFDS), to apply for a classification that would be analogous to the company's Class III submissions with the USFDA and the Therapeutics Goods Administration in Australia. This submission is scheduled for early 2018.
United Health Products Completes Multiple FDA Required Tests for HemoStyp(R)Font size: A | A | A
8:30 AM ET 12/18/17 | GlobeNewswire
United Health Products Completes Multiple FDA Required Tests for HemoStyp(R)
Will Apply for South Korea MFDS Classification
HENDERSON, Nev., Dec. 18, 2017 (GLOBE NEWSWIRE) -- United Health Products, Inc. (UHP) (OTC:UEEC), manufacturer and marketer of HemoStyp, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that it has completed an array of tests required as a part of a FDA submission. The biocompatibility tests, which were conducted at independent laboratories Nelson Labs and EMSL Analytical, tested for irritability, sensitivity, cytoxcity, and absorption of the company's HemoStyp product. Results from the tests exceeded the performance of any competitive products known to the company. The results will be published on the company's website following presentation to the FDA and other international regulatory agencies in Australia and South Korea.
Separately, UHP is pleased to announce that its South Korean distribution partner in South Korea has prepared a submission for HemoStyp with the South Korean Ministry of Food and Drug Safety (MFDS), to apply for a classification that would be analogous to the company's Class III submissions with the USFDA and the Therapeutics Goods Administration in Australia. This submission is scheduled for early 2018.
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