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Immunostics Inc.,

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K221817ALFIS Vitamin D, ALFIS-3 AnalyzerSeptember 22, 2023
K182298hemochroma PLUS SystemNovember 16, 2018
K163465hemochroma PLUS SystemSeptember 8, 2017
K163225AFIAS iFOB with AFIAS-50August 8, 2017
K171484hema-screen SPECIFIC GoldJune 14, 2017
K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestJanuary 17, 2017
K102664HEMA SCREEN ERJanuary 28, 2011
K060463HEMA SCREEN SPECIFIC IFOBTJune 6, 2006
K041728HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTEAugust 11, 2004
K031490RUBELLACOLJuly 16, 2003
K992759COLON ALERT TESTDecember 6, 1999
K972457MONOCOL/LEX-IM TESTDecember 1, 1997
K972456RHEUMACOL RHEUMATOID FACTOR TESTNovember 25, 1997
K972606PREGNACOL PREGNANCY TESTAugust 29, 1997