Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

OAV · Predicate Candidate Screening

3 FDA 510(k) clearances under this product code; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K102772DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DSiemens Heatlhcare Diagnostics, Inc.2011-10-073780
K081083CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLICThermo Fisher Scientific2008-12-192470
K063520ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLRoche Diagnostics2007-02-16870

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