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Immunostics Inc.,

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

Total Devices6
Categories4
Latest FDA decision2023-09-22
TypeNumberDevice NameCodeDateActions
510(k) K221817 ALFIS Vitamin D, ALFIS-3 AnalyzerMRG2023-09-22 View
510(k) K182298 hemochroma PLUS SystemGKR2018-11-16 View
510(k) K163465 hemochroma PLUS SystemGKR2017-09-08 View
510(k) K163225 AFIAS iFOB with AFIAS-50OOX2017-08-08 View
510(k) K171484 hema-screen SPECIFIC GoldKHE2017-06-14 View
510(k) K163554 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE2017-01-17 View
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