Atlas FDA

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

Granbio, Inc. — Predicate Candidate Screening

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

141 daysmedian FDA review time
301 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K951822EBNA ENZYME IMMUNOASSAY KITGranbio, Inc.1996-02-153010
K934774UNKNOWNGranbio, Inc.1994-04-201970
K901840(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, Inc.1990-09-121410
K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, Inc.1990-09-121830
K881617INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAYGranbio, Inc.1988-06-07530
K871298EBNA ACIF ASSAY KITGranbio, Inc.1987-06-25860
K864347INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCAGranbio, Inc.1987-02-02900
K864604EBV VCA IGM ANTIBODY ASSAY KITGranbio, Inc.1987-02-02700

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