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Immunostics Inc.,

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
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
510(k) K102664 HEMA SCREEN ERKHE2011-01-28 View
510(k) K060463 HEMA SCREEN SPECIFIC IFOBTKHE2006-06-06 View
510(k) K041728 HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTEJHI2004-08-11 View
510(k) K031490 RUBELLACOLLQN2003-07-16 View
510(k) K992759 COLON ALERT TESTKHE1999-12-06 View
510(k) K972457 MONOCOL/LEX-IM TESTKTN1997-12-01 View
510(k) K972456 RHEUMACOL RHEUMATOID FACTOR TESTDHR1997-11-25 View
510(k) K972606 PREGNACOL PREGNANCY TESTJHJ1997-08-29 View
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