Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Immunostics Inc.,

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories4
Latest Approval2023-09-22
TypeNumberDevice NameCodeDate
510(k) K221817 ALFIS Vitamin D, ALFIS-3 Analyzer MRG 2023-09-22 View
510(k) K182298 hemochroma PLUS System GKR 2018-11-16 View
510(k) K163465 hemochroma PLUS System GKR 2017-09-08 View
510(k) K163225 AFIAS iFOB with AFIAS-50 OOX 2017-08-08 View
510(k) K171484 hema-screen SPECIFIC Gold KHE 2017-06-14 View
510(k) K163554 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test KHE 2017-01-17 View
↑