Partner
Concern-Energomash CJSC
GeneProof lists Concern-Energomash CJSC in its distributor directory for Armenia.
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Partner
GeneProof lists Concern-Energomash CJSC in its distributor directory for Armenia.
Glossary Term
A US pathway in which a device maker demonstrates substantial equivalence to a legally marketed predicate. For IVD test kits, 510(k) clearance documents intended use and analytical/clinical support; it is distinct from CLIA waiver, which concerns point-of-care operation settings.