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

Sweden Diagnostics (Germany) GmbH · Predicate Candidate Screening

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

72 daysmedian FDA review time
89 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbH2005-06-28710
K050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH2005-04-26460
K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbH2004-12-08720
K041173CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996Sweden Diagnostics (Germany) GmbH2004-08-02890
K041357VARELISA GLIADIN IGG ANTIBODIESSweden Diagnostics (Germany) GmbH2004-08-02740
K041174CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148Sweden Diagnostics (Germany) GmbH2004-07-19750
K041354VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896Sweden Diagnostics (Germany) GmbH2004-07-16570
K041040VARELISA MPO ANCA, MODEL 17648/17696Sweden Diagnostics (Germany) GmbH2004-06-16550

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