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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Euroimmun Us, LLC · Predicate Candidate Screening

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

255 daysmedian FDA review time
421 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070789EUROIMMUN ANTI-CCP ELISAEuroimmun Us, LLC2007-12-312840
K061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) Euroimmun Us, LLC2007-06-284210
K070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC2007-05-22630
K061408EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KITEuroimmun Us, LLC2006-10-051360
K060700EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.Euroimmun Us, LLC2006-09-081770
K051489EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY Euroimmun Us, LLC2006-02-162550

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