$ARYC Microarray product line has been submitted to the FDA & now pending approval.
1-2-18: Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance https://www.fda.gov
Arrayit business development team reports revenues and earnings expansion opportunity with a leading allergy testing clinic headquartered in San Antonio Texas USA and serving the massive health and wellness allergy and asthma testing services markets (link: http://arrayit.com/Clinical/clinical.html) arrayit.com/Clinical/clini…
Arrayit business development team reports revenues and earnings expansion opportunity with a leading allergy testing clinic headquartered in San Antonio Texas USA and serving the massive health and wellness allergy and asthma testing services markets https://t.co/TRfj3lWfRdpic.twitter.com/CZdPimKrtf
Market’s first high-performance blood card technology... Blood card technology is pending 510(k) submission and is not to be used for in vitro diagnostics prior to FDA approval.
The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.
Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.
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