Atlas FDA

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

Fairleigh Dickinson Laboratories, Inc. · Predicate Candidate Screening

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

74 daysmedian FDA review time
138 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K896032MODIFIED ELISA FOR CHLAMYDIAFairleigh Dickinson Laboratories, Inc.1990-01-291050
K895187FDL, INC.'S TRANSPORT SYSTEMFairleigh Dickinson Laboratories, Inc.1989-10-24740
K883266FDL ELISA FOR CHLAMYDIAFairleigh Dickinson Laboratories, Inc.1988-10-25830
K881502BREWER GEL FOR CAMPYLOBACTERFairleigh Dickinson Laboratories, Inc.1988-04-27160
K875362BREWER GEL FOR ANAEROBESFairleigh Dickinson Laboratories, Inc.1988-01-27270
K853307DIRECT ELISA FOR HERPES SIMPLEX VIRUSFairleigh Dickinson Laboratories, Inc.1985-12-231380
K850251ROTALOK SURGICAL HAND TABLEFairleigh Dickinson Laboratories, Inc.1985-02-28370

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