Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Immunostics Inc., — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

111 daysmedian FDA review time
270 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K221817ALFIS Vitamin D, ALFIS-3 AnalyzerImmunostics Inc.,2023-09-224570
K182298hemochroma PLUS SystemImmunostics Inc.,2018-11-16840
K163465hemochroma PLUS SystemImmunostics Inc.,2017-09-082700
K163225AFIAS iFOB with AFIAS-50Immunostics Inc.,2017-08-082640
K171484hema-screen SPECIFIC GoldImmunostics Inc.,2017-06-14230
K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Immunostics Inc.,2017-01-17290
K102664HEMA SCREEN ERImmunostics Inc.,2011-01-281350
K060463HEMA SCREEN SPECIFIC IFOBTImmunostics Inc.,2006-06-061040
K041728HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTEImmunostics Inc.,2004-08-11470
K031490RUBELLACOLImmunostics Inc.,2003-07-16650
K992759COLON ALERT TESTImmunostics Inc.,1999-12-061110
K972457MONOCOL/LEX-IM TESTImmunostics Inc.,1997-12-011530
K972456RHEUMACOL RHEUMATOID FACTOR TESTImmunostics Inc.,1997-11-251470
K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,1997-08-29490

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda